Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
2,666
Countries
23
Sites
157
Nervous system diseases
To determine the long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis (RMS) and progressive multiple sclerosis (PMS)
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 20 May 2024 → ongoing
- Decision date (initial)
- 2024-05-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sanofi-Aventis Research & Development
External identifiers
- EU CT number
- 2023-503631-18-01
- WHO UTN
- U1111-1287-6797
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To determine the long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis (RMS) and progressive multiple sclerosis (PMS)
Secondary objectives 1
- To assess long-term efficacy of open label (OL) tolebrutinib on disability progression, relapse rate (only in participants with RMS), and magnetic resonance imaging (MRI) parameters in participants with RMS and PMS
Conditions and MedDRA coding
Nervous system diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10080700 | Relapsing multiple sclerosis | 100000004852 |
| 21.1 | PT | 10063400 | Secondary progressive multiple sclerosis | 100000004852 |
| 21.1 | PT | 10067063 | Progressive relapsing multiple sclerosis | 100000004852 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of the trial participants. Further details on Sanofi´s data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-000637-41 | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis , Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s teriflunomidem (Aubagio®) u pacientů s relabujícími formami roztroušené sklerózy (GEMINI 1), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s teriflunomidem (Aubagio®) u pacientů s relabujícími formami roztroušené sklerózy (GEMINI 1), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s teriflunomidem (Aubagio®) u pacientů s relabujícími formami roztroušené sklerózy (GEMINI 1), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s teriflunomidem (Aubagio®) u pacientů s relabujícími formami roztroušené sklerózy (GEMINI 1), Studio di Fase 3, randomizzato, in doppio cieco, di efficacia e sicurezza che confronta SAR442168 verso teriflunomide (Aubagio®) in partecipanti affetti da forme recidivanti di sclerosi multipla | |
| 2020-000647-30 | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis, Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u účastníků s nerelabující sekundárně progresivní roztroušenou sklerózou, Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u účastníků s nerelabující sekundárně progresivní roztroušenou sklerózou, Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u účastníků s nerelabující sekundárně progresivní roztroušenou sklerózou, Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u účastníků s nerelabující sekundárně progresivní roztroušenou sklerózou, Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u účastníků s nerelabující sekundárně progresivní roztroušenou sklerózou, Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με μη υποτροπιάζουσα δευτεροπαθώς προϊούσα σκλήρυνση κατά πλάκας (HERCULES)., Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με μη υποτροπιάζουσα δευτεροπαθώς προϊούσα σκλήρυνση κατά πλάκας (HERCULES)., Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με μη υποτροπιάζουσα δευτεροπαθώς προϊούσα σκλήρυνση κατά πλάκας (HERCULES)., Estudio de eficacia y seguridad de fase 3, aleatorizado y doble ciego que compara SAR442168 con placebo en participantes con esclerosis múltiple secundaria progresiva no recidivante, III. fázisú, randomizált, kettős vak vizsgálat a SAR442168 hatásosságának és biztonságosságának placebóval szembeni értékelésére, nem relapszáló szekunder progresszív szklerózis multiplexben szenvedő betegek körében, III. fázisú, randomizált, kettős vak vizsgálat a SAR442168 hatásosságának és biztonságosságának placebóval szembeni értékelésére, nem relapszáló szekunder progresszív szklerózis multiplexben szenvedő betegek körében, Studio di Fase 3, randomizzato, in doppio cieco, di efficacia e sicurezza, che confronta SAR442168 verso placebo in pazienti affetti da sclerosi multipla progressiva secondaria non recidivante (HERCULES) | |
| 2023-503631-18-00 | An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis | Sanofi-Aventis Research & Development |
| 2020-000645-14 | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u pacientů s primárně progresivní roztroušenou sklerózou (PPRS), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u pacientů s primárně progresivní roztroušenou sklerózou (PPRS), Randomizovaná, dvojitě zaslepená studie fáze 3 hodnotící účinnost a bezpečnost přípravku SAR442168 ve srovnání s placebem u pacientů s primárně progresivní roztroušenou sklerózou (PPRS), Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με πρωτοπαθή προϊούσα σκλήρυνση κατά πλάκας (PERSEUS)., Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με πρωτοπαθή προϊούσα σκλήρυνση κατά πλάκας (PERSEUS)., Μια φάσης 3 τυχαιοποιημένη, διπλά τυφλή μελέτη αποτελεσματικότητας και ασφάλειας για τη σύγκριση του SAR442168 με το εικονικό φάρμακο σε συμμετέχοντες με πρωτοπαθή προϊούσα σκλήρυνση κατά πλάκας (PERSEUS)., III. fázisú, randomizált, kettős vak vizsgálat a SAR442168 hatásosságának és biztonságosságának placebóval szembeni értékelésére, primer progresszív szklerózis multiplexben szenvedő résztvevőknél, III. fázisú, randomizált, kettős vak vizsgálat a SAR442168 hatásosságának és biztonságosságának placebóval szembeni értékelésére, primer progresszív szklerózis multiplexben szenvedő résztvevőknél, III. fázisú, randomizált, kettős vak vizsgálat a SAR442168 hatásosságának és biztonságosságának placebóval szembeni értékelésére, primer progresszív szklerózis multiplexben szenvedő résztvevőknél, Estudio en fase 3, aleatorizado, doble ciego para evaluar la eficacia y seguridad del tratamiento con SAR442168 frente a placebo en pacientes con esclerosis múltiple primaria progresiva (PERSEUS), Studio di Fase 3, randomizzato, in doppio cieco, di efficacia e sicurezza, che confronta SAR442168 con placebo in partecipanti affetti da sclerosi multipla progressiva primaria (PERSEUS), Randmizirano, dvostruko slijepo ispitivanje sigurnosti i učinkovitosti 3. faze u kojem se uspoređuje lijek SAR442168 s placebom u ispitanika s primarno-progresivnom multiplom sklerozom (PERSEUS), Randmizirano, dvostruko slijepo ispitivanje sigurnosti i učinkovitosti 3. faze u kojem se uspoređuje lijek SAR442168 s placebom u ispitanika s primarno-progresivnom multiplom sklerozom (PERSEUS), Randmizirano, dvostruko slijepo ispitivanje sigurnosti i učinkovitosti 3. faze u kojem se uspoređuje lijek SAR442168 s placebom u ispitanika s primarno-progresivnom multiplom sklerozom (PERSEUS) | |
| 2018-004731-76 | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis, Dlhodobá štúdia sledujúca bezpečnosť a účinnosť SAR442168 u pacientov s relapsujúcou sklerózou multiplex, Dlouhodobá studie sledující bezpečnost a účinnost SAR442168 u pacientů s relabující roztroušenou sklerózou, Dlouhodobá studie sledující bezpečnost a účinnost SAR442168 u pacientů s relabující roztroušenou sklerózou, Estudio de extensión a largo plazo de seguridad y eficacia de SAR442168 en participantes con esclerosis múltiple recurrente |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
- OR - The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
- ToleDYNAMIC Substudy: Inclusion criteria are those of the main study
Exclusion criteria 11
- The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
- For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
- Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
- Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
- Abnormal ECG during the opt-in visit considered in the Investigator’s judgment to be clinically significant, such as QTcF >500 msec, in the context of this study.
- A bleeding disorder, known platelet dysfunction, abnormal platelet count (<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
- For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
- Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
- Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
- The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
- ToleDYNAMIC Substudy: Exclusion criteria are those of the main study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation
- Number of Participants with Potentially clinically significant abnormalities (PCSAs
Secondary endpoints 5
- Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies
- Annualized Relapse Rate (ARR) for RMS only
- Number of new and/or enlarging T2-hyperintense lesions per year
- Change from baseline in total volume of T2-hyperintense lesions
- ToleDYNAMIC substudy Change from baseline in biomarkers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10454961 · Product
- Active substance
- Tolebrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
AUBAGIO 14 mg film-coated tablets
PRD2675141 · Product
- Active substance
- Teriflunomide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 14 mg milligram(s)
- Max total dose
- 14 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA31 — -
- Marketing authorisation
- EU/1/13/838/002
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Matched Placebo for Comparator Teriflunomide
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 3
V08C · Product
- Active substance
- Magnetic Resonance Imaging Contrast Media
- Pharmaceutical form
- -
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08C — MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP30086892 · ATC
- Active substance
- Anhydrous Cholestyramine
- Route of administration
- ORAL USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C10AC01 — COLESTYRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
SCP4987633 · ATC
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A07B — INTESTINAL ADSORBENTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Research & Development
- Contact name
- Clinical Sciences and Operations
Third parties 21
| Organisation | City, country | Duties |
|---|---|---|
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| Pharmalink Sp. z o.o. ORG-100019134
|
Lodz, Poland | Code 14 |
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Radomsko, Poland | Code 14, Other |
| Apoteket AB ORG-100021562
|
Uppsala, Sweden | Code 14 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| PetMobile Kft. ORG-100047817
|
Budakalasz, Hungary | Code 14 |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Affidea Magyarorszag Kft. ORG-100047239
|
Budapest VIII, Hungary | Laboratory analysis |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Laboratory analysis |
| Capital Medical Point Kft. ORG-100053779
|
Budapest XIII, Hungary | Other |
| Oriola Finland Oy ORG-100013290
|
Espoo, Finland | Code 14 |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
| Neurorx Research Inc. ORG-100046079
|
Montreal, Canada | Other |
| Tamro AB ORG-100012530
|
Hisings Backa, Sweden | Code 14 |
| Ashfield Iberia S.L. ORG-100055590
|
Madrid, Spain | Other |
| Koneksa Health Inc. ORG-100045905
|
New York, United States | E-data capture |
| Oriola Finland Oy ORG-100013290
|
Espoo, Finland | Code 14 |
| PHOENIX lekarensky velkoobchod s.r.o. ORG-100019669
|
Prague, Czechia | Code 14 |
Locations
23 EU/EEA countries · 157 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 24 | 3 |
| Belgium | Ongoing, recruiting | 55 | 7 |
| Bulgaria | Ongoing, recruiting | 120 | 8 |
| Croatia | Ongoing, recruiting | 28 | 2 |
| Czechia | Ongoing, recruiting | 230 | 11 |
| Denmark | Ongoing, recruiting | 12 | 3 |
| Estonia | Ongoing, recruiting | 19 | 1 |
| Finland | Ongoing, recruitment ended | 10 | 2 |
| France | Ongoing, recruiting | 155 | 16 |
| Germany | Ongoing, recruiting | 104 | 14 |
| Greece | Ongoing, recruiting | 55 | 7 |
| Hungary | Ongoing, recruiting | 37 | 4 |
| Italy | Ongoing, recruiting | 100 | 15 |
| Latvia | Ongoing, recruitment ended | 10 | 2 |
| Lithuania | Ongoing, recruitment ended | 15 | 3 |
| Netherlands | Ongoing, recruiting | 16 | 4 |
| Norway | Ongoing, recruiting | 10 | 2 |
| Poland | Ongoing, recruiting | 135 | 10 |
| Portugal | Ongoing, recruiting | 23 | 8 |
| Romania | Ongoing, recruiting | 65 | 8 |
| Slovakia | Ongoing, recruitment ended | 11 | 3 |
| Spain | Ongoing, recruiting | 164 | 22 |
| Sweden | Ongoing, recruiting | 7 | 2 |
| Rest of world
United Arab Emirates, Mexico, Chile, Malaysia, Georgia, South Africa, Turkey, Peru, Singapore, India, Japan, Brazil, Thailand, Canada, Serbia, China, Australia, Argentina, Tunisia, Israel, Egypt, United States, Hong Kong, United Kingdom, Korea, Republic of, Taiwan, Colombia
|
— | 1,261 | — |
Investigational sites
Medizinische Universitaet Innsbruck
University Hospital for Neurology, Anichstrasse 35, 6020, Innsbruck
Medical University of Vienna
Department of Neurology, Spitalgasse 23, Alsergrund, Vienna
Kepler Universitaetsklinikum GmbH
Department of Neurology, Krankenhausstrasse 9, 4020, Linz
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Noorderhart
Neurology, Boemerangstraat 2, 3900, Pelt
CHU De Liege
Neurology, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Neurology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az St-Jan Brugge-Oostende A.V.
Neurology, Ruddershove 10, 8000, Brugge
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
Diagnostics And Consultation Center Convex Ltd.
Diagnostic Consultative Center Convex, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Alexandrovska University Hospital
Clinic of Neurology Diseases, Georgy Sofiiski Str 1, 1431, Sofia
Acibadem City Clinic Tokuda University Hospital EAD
Clinic of Neurology and Sleep Medicine, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Neurology Diseases, Bulevard Peshtersko Shose 66, 4002, Plovdiv
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Neurology Diseases, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Neurology Clinic, Ulitsa Georgi Kochev 8-A, 5803, Pleven
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department of Multiple Sclerosis, Ul. Dr. Lyuben Rusev 1, 1113, Sofia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department of Nervous Diseases, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
University Hospital Centre Zagreb
Department of Neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Klinicki bolnicki centar Sestre milosrdnice
Department of Neurology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Krajska zdravotni a.s.
Neurologicke oddeleni, Duchcovska 53, 415 01, Teplice
Fakultni Nemocnice U Sv Anny V Brne
I. neurologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
Nemocnice Pardubickeho kraje a.s.
Neurologicka klinika, Kyjevska 44 Pardubicky, 530 03, Pardubice
Fakultni Nemocnice Kralovske Vinohrady
Neurologicka klinika 3. LF UK a FNKV, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Hradec Kralove
Neurologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Neurologicka klinika, Jihlavska 340/20, Bohunice, Brno
Nemocnice Jihlava prispevkova organizace
Neurologicke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Vseobecna Fakultni Nemocnice V Praze
MS Centrum, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Fakultni Nemocnice Ostrava
Neurologicka klinika, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice V Motole
Neurologicka klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague 5
Krajska Nemocnice T Bati a.s.
Neurologicke oddeleni, Havlickovo Nabrezi 600, 760 01, Zlin
Odense University Hospital
Neurolog, J B Winsloews Vej 4, 5000, Odense C
Region Midtjylland
Neurology, Physiotherapy and Occupational Therapy, Hospitalsparken 15, 7400, Herning
Sydvestjysk Sygehus
Neurology, Finsensgade 35, 6700, Esbjerg
Turku University Hospital
Turun Yliopistollinen Keskussairaala( #1), Hameentie 11, 20520, Turku
Pirkanmaan hyvinvointialue
FinnMedi Tutkimusvastaanotto (#1), Biokatu 12, 33520, Tampere
CHRU De Nancy
Neurology, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Centre Hospitalier Intercommunal De Poissy Saint Germain
Neurology, Residence Les Maisonnees, 10 Rue Du Champ Gaillard, Poissy
Centre Hospitalier Universitaire De Nimes
Neurology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Les Hopitaux Universitaires De Strasbourg
Neurology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Toulouse
Neurology, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Centre Hospitalier General
Neurology, 2 Boulevard Du 19 Mars 1962, 95500, Gonesse
Hospices Civils De Lyon
Neurology, 59 Boulevard Pinel, 69500, Bron
Assistance Publique Hopitaux De Paris
Neurology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Nantes
Neurology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
University Hospital Of Montpellier
Neurology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Lille
Neurology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Regional Universitaire
Neurology, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Universitaire De Rennes
Neurology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nice
Service de Neurosciences, 30 Voie Romaine, 06000, Nice
Hopital Fondation Adolphe De Rothschild
Neurology, 25 Rue Manin, 75019, Paris
CHU Gabriel-Montpied
Neurology, 58 Rue Montalembert, 63000, Clermont Ferrand
Technische Universitat Dresden
Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Neurologisches Facharztzentrum Berlin
Neurologie, Paretzer Str. 12, 10713, Berlin
MultipEL Studies
Neurologie, Institut fur klinische Studien GbR Bengelsdorfstrasse 5, 22179, Hamburg
Klinikum Bayreuth GmbH
Klinik fur Neurologie, Hohe Warte 8, Gruener Baum, Bayreuth
Klinikum Wuerzburg Mitte gGmbH
Klinik für Neurologie & Neurologische Frührehabilitation (Phase B), Salvatorstrasse 7, Frauenland, Wuerzburg
Klinikum der Universitaet Muenchen AöR
Klinik fur Neurologie, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Essen AöR
Neurologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Ulm AöR
Neurologie, Oberer Eselsberg 45, Eselsberg, Ulm
Justus-Liebig-Universitaet Giessen
Fachbereich Medizin, Klinikstrasse 33, 35392, Giessen
Charite Universitaetsmedizin Berlin KöR
Exzellenzcluster NeuroCure, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Duesseldorf AöR
neurologie, Geb. 22.21, Universitätsstraße 1, Düsseldorf
Katholisches Klinikum Bochum gGmbH
Neurologie, Gudrunstrasse 56, Grumme, Bochum
neurologie.berlin
N/A, Neurologie im Tempelhofer Hafen Berlin GbR Tempelhofer Damm 227, 12099, Berlin
Universitaetsklinikum Muenster AöR
Neurologie, Albert-Schweitzer-Campus 1, Sentrup, Münster
University General Hospital Of Thessaloniki Ahepa
2nd Neurology Clinic,( #1), 1st St Kiriakidis Str, 546 36, Thessaloniki
St. Luke's Hospital S.A.
Neurology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
University General Hospital Attikon
2nd Neurology Clinic, Rimini Street 1, 124 62, Athens
401 General Military Hospital Of Athens
Neurology Clinic, Panagioti Kanellopoulou Av 1, 115 25, Athens
Athens Medical Center S.A.
Neurology Department, Distomou 5-7, 151 25, Maroussi
Eginitio Hospital
1st University Neurology Clinic, Vassilissas Sofias Avenue 74, 115 28, Athens
General University Hospital Of Larissa
Neurology Clinic, P. O. Box 1425, 411 10, Larissa
S-Medicon Kft.
S-Medicon Egeszsegugyi Szolgaltato Kft., Megyeri Ut 53, 1044, Budapest IV
Clinexpert Kft.
Clinexpert Gyogycentrum( #1), Kaszasdulo Utca 5, 1033, Budapest III
Uno Medical Trials Kft.
Uno Medical Trials Kft. (#1), Vecsey Karoly Utca 39, 1152, Budapest XV
University Of Pecs
Klinikai Kozpont, Neurologiai Klinika, Ret Utca 2, 7623, Pecs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOS Sclerosi Multipla, Largo Francesco Vito 1, 00168, Rome
IRCCS Ospedale Policlinico San Martino
DINOGMI - Dip. di neuroscienze, riabilitazione, oftalmologia, genetica e scienze materno-infantili, Largo Rosanna Benzi 10, 16132, Genoa
Universita' Degli Studi G. D'annunzio Di Chieti
CAST - Center for Advanced Studies and Technology, Via Dei Vestini 31, 66100, Chieti
Careggi University Hospital
SOD Neurologia II, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
U.O.C. “Neurologia II”, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Neurology department, Via Atinense N. 18, 86077, Pozzilli
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Centro Sclerosi Multipla, Ospedale Marino, Viale Poetto N. 12, Cagliari
Neurological Institute Foundation Casimiro Mondino
U.O Neurologia generale, Unità Operativa Sclerosi Multipla, Via Casimiro Mondino 2, 27100, Pavia
Careggi University Hospital
Dipartimento NEUROFARBA, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Papa Giovanni XXIII
USC Neurologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero-Universitaria Sant Andre
U.O.C. Neurologia, Via Di Grottarossa 1035-1039, 00189, Rome
Ospedale San Raffaele S.r.l.
Centro Sclerosi Multipla Dimer, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Centro Sclerosi Multipla, Via Santa Sofia 78, 95123, Catania
San Camillo Forlanini Hospital
Dipartimento Testa Collo e delle Neuroscienze, Circonvallazione Gianicolense 87, 00152, Rome
IRCCS Foundation Istituto Neurologico Carlo Besta
Neuroimmunology and Neuromuscolar Disease Unit, Via Giovanni Celoria 11, 20133, Milan
Latvijas Juras medicinas centrs AS
Department of Neurology, Patversmes Iela 23, LV-1005, Riga
Pauls Stradins Clinical University Hospital
Department of Neurology, Pilsonu Iela 13, 1002, Riga
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Center of Neurology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Republican Siauliai Hospital
Neurology department, V. Kudirkos G. 99, Siauliu M. Sav., Siauliai
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Neurology department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Zuyderland Medisch Centrum Stichting
Department of Neurology, Henri Dunantstraat 5, 6419 PC, Heerlen
Amsterdam UMC
Department of Neurology, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Martini Ziekenhuis
Department of Neurology, Van Swietenplein 1, 9728 NT, Groningen
Amphia Hospital
Department of Neurology, Molengracht 21, 4818 CK, Breda
Oslo University Hospital HF
Nevrologisk avdeling, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Nevrologisk avdeling, Jonas Lies Vei 65, 5021, Bergen
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Klinika Neurologii i Udarów Mózgu, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Neuroprotect Sp. z o.o.
NA, Ul. Klaudyny 16c, 01-684, Warsaw
Szpital Wolski Im. Dr Anny Gostynskiej Sp. z o.o.
Oddzial udarowy, neurologii i pododdzial rehabilitacji neurologicznej, Ul. Ulica Marcina Kasprzaka 17, 01-211, Warsaw
Wielospecjalistyczne Centrum Medyczne IBISMED S.C
NA, ul. Banachiewicza 11, 41-800, Zabrze
Neurocentrum Bydgoszcz Sp. z o.o.
NA, Ul. Aleje Prof. Sylwestra Kaliskiego 28/U1, 85-796, Bydgoszcz
Nowe Techniki Medyczne Szpital Specjalistyczny Imienia Swietej Rodziny Sp. z o.o.
Oddzial Neurologii, Ul. Rudna Mala 600, Rudna Mala, Glogow Malopolski
Ma-Lek Clinical Sp. z o.o.
NA, Ul. Zaleska 9, 40-571, Katowice
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
NA, ul. Fabianowska 40, 62-064, Plewiska
Neuro-Medic Sp. z o.o.
NA, Ul. Zurawia 80, 40-686, Katowice
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
NA, Ul. 1 Maja 14, 20-410, Lublin
Centro Hospitalar E Universitario De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3000-459, Coimbra
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
Neurology, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
Centro Hospitalar De Lisboa Ocidental E.P.E.
Neurology, Rua Da Junqueira 126, 1349-019, Lisbon
Hospital Pedro Hispano
Neurology, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
CCAB Centro Clinico Academico Braga Associacao
Neurology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Hospital Da Luz S.A.
Neurology, Avenida Lusiada 100, 1500-650, Lisbon
Centro Hospitalar Universitario Lisboa Central E.P.E.
Neurology, Rua Jose Antonio Serrano, 1150-199, Lisbon
Hospital De Santa Maria E.P.E.
Neurology, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Neurologie, Strada Crisului Nr. 1, 500283, Brasov
Institutul Clinic Fundeni
Neurologie I, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Neurologie, Strada Pasteur Louis Nr 26, 410154, Oradea
Aria Clinic S.R.L.
Neurologie, Soseaua Alba Iulia Nr 100, 550052, Sibiu
Clubul Sanatatii S.R.L.
Neurologie, Bulevardul Bratianu I. C. 54b, 115100, Campulung
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Neurologie II, Bulevardul Liviu Rebreanu 156, 300723, Timisoara
Spitalul Clinic Cai Ferate Constanta
Neurologie, Bulevardul 1 Mai 5-7, 900123, Constanta
Spitalul Clinic Judetean De Urgenta Cluj
Sectia Neurologie I, Strada Profesor Victor Babes 43, 400012, Cluj-Napoca
Fakultna Nemocnica Nitra
Neurologicka klinika, Spitalska 6, Stare Mesto, Nitra
Univerzitna Nemocnica Martin
Neurologicka klinika, Kollarova 2, 036 01, Martin
University Hospital Bratislava
Neurologicka klinika, Ruzinovska 6, Ruzinov, Bratislava
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Neurology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Vall D'hebron Institut De Recerca
Neurology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Complexo Hospitalario Universitario A Coruna
Neurology, Lugar Jubias De Arriba 84, 15006, A Coruna
University Clinical Hospital Virgen De La Arrixaca
Neurology, Carretera De Cartagena Sn, El Palmar, Murcia
University Hospital Son Espases
Neurology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario De Cruces
Neurology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Donostia
Neurology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Quironsalud Madrid
Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
El Hospital Universitario De Gran Canaria Dr. Negrin
Neurology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Puerta De Hierro De Majadahonda
Neurology, Calle De Manuel De Falla 1, 28222, Majadahonda
Complexo Hospitalario Universitario De Santiago
Neurology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari De Girona Doctor Josep Trueta
Neurology, Avinguda De Franca S/n, 17007, Girona
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28009, Madrid
El Hospital Universitario De Gran Canaria Dr. Negrin
Servicio de Neurologia, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinico San Carlos
Neurology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Reina Sofia
Neurology, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-06-27 | 2024-06-27 | |||
| Belgium | 2024-05-27 | 2024-05-27 | |||
| Bulgaria | 2024-06-18 | 2024-06-18 | |||
| Croatia | 2024-06-10 | 2024-06-10 | |||
| Czechia | 2024-05-27 | 2024-05-27 | |||
| Denmark | 2024-06-07 | 2024-06-07 | |||
| Estonia | 2024-05-21 | 2024-05-21 | |||
| Finland | 2024-06-11 | 2024-06-11 | 2024-09-06 | ||
| France | 2024-05-22 | 2024-05-22 | |||
| Germany | 2024-05-27 | 2024-05-27 | |||
| Greece | 2024-07-02 | 2024-07-02 | |||
| Hungary | 2024-06-17 | 2024-06-17 | |||
| Italy | 2024-06-11 | 2024-06-11 | |||
| Latvia | 2024-05-22 | 2024-05-22 | 2024-06-18 | ||
| Lithuania | 2024-06-06 | 2024-06-06 | 2024-07-01 | ||
| Netherlands | 2024-06-20 | 2024-06-20 | |||
| Norway | 2024-06-19 | 2024-06-19 | |||
| Poland | 2024-05-20 | 2024-05-20 | |||
| Portugal | 2024-06-19 | 2024-06-19 | |||
| Romania | 2024-06-19 | 2024-06-19 | |||
| Slovakia | 2024-06-06 | 2024-06-06 | 2024-06-27 | ||
| Spain | 2024-05-28 | 2024-05-28 | |||
| Sweden | 2024-05-28 | 2024-05-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 198 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-el-2023-503631-18 | 10 |
| Protocol (for publication) | d1-rdct-protocol-en-2023-503631-18 | 10 |
| Protocol (for publication) | d4-patient-facing-material-copyright-list-en-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-bg-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-cs-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-de-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-de-AT-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-el-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-en-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-es-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-et-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-fr-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-fr-BE-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-hr-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-hu-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-it-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-lt-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-lv-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-nl-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-nl-BE-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-pt-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-ro-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-sk-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-sv-2023-503631-18 | 1 |
| Protocol (for publication) | d4-patient-facing-material-phq9-UA-2023-503631-18 | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-bg | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 2 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-fi | 2 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-fr | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-lt | 2 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-pl | 2 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-sv | 3 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-actigraphy-cs | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-addendum4-cs | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-addendum4-sk | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-fr | 8 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16033-de | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16033-translated-uk | 1.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16034-de | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16034-translated-uk | 1.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16035-de | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-based-on-EFC16645-de | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-bg | 5 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-cs | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-da | 9 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-ee | 6.2 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-el | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-en | 5 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-en | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-es | 13 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-gem-fi | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-gem1-lt | 9 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-gemini2-nl | 2 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-her-fi | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-her-lt | 10 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-hercules-nl | 2 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-hr | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-lv | 6 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-perseus-nl | 3 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-pms-en | 8 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-pms-fr | 8 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-pms-nl | 8 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-pt | 13 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-rms-en | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-rms-fr | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-rms-nl | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-ro | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-ru | 6 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-ru | 6.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-sk | 6 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-main-sv | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-optional-biomarkers-el | 1.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-optional-genetic-research-el | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-optional-kinesiography-el | 1.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-optional-substudies-lt | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-de | 5.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-hu | 6.0 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-instruction-gem-fi | 5 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-instruction-her-fi | 6 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-it | 5.2 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-no | 7 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-pl | 8 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-patient-translated-uk | 3.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-pharmacogeneticresearch-hr | 2.1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-pharmacogenetics-cs | 2 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-pharmacogenetics-sk | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-bg | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-en | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-hr | 1.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum1-cs | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum1-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum1-nl | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum1-sk | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum2-cs | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum2-sk | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum3-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum3-sk | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-child-pregnancy-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-female-partner-pregnancy-fr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-research-da | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-sample-use-cs | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-sample-use-sk | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-samples-lt | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-futureresearch-hr | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-genetic-patient-information-genetic-informed-consent-hu | 1.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-homenursingservice-hr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-nl-addendum2 | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-male-partner-pregnancy-fr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-mri-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-mri-sk | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-direct-to-patient-el | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-future-use-el | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-home-nurse-service-el | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-female-pregnancy-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-bg | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-cs | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-da | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-ee | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-el | 1.4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-en | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-es | 5.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-fi | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-fr | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-hu | 3.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-it | 1.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-lt | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-lv | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-nl | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-no | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-pl | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-pt | 5.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-ro | 2.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-ru | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-ru | 1.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-sk | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-sv | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-translated-uk | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partnerpregnancy-hr | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-nl | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnantpatient-hr | 2.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-data-cs | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-data-sk | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-it | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-translated-uk | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-procedure-lt | 1 |
| Subject information and informed consent form (for publication) | L1-sis-partner-pregnancy-en | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-addendum-ro | 1.1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-confidentality-release-de | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-confidentality-release-translated-uk | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-gpletter-it | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-leaflet-da | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-local-site-information-de | 3 |
| Subject information and informed consent form (for publication) | L2-redacted-other-subject-information-administrative-letter-fr | 1 |
| Subject information and informed consent form (for publication) | L2-redacted-other-subject-information-material-patient card open label 1-hu | 1 |
| Subject information and informed consent form (for publication) | L2-redacted-other-subject-information-material-patient-card-open-label-hu | 2 |
| Subject information and informed consent form (for publication) | L2-redacted-subject-information-material-patient card double blind-hu | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | e1-smpc-teriflunomide-ema-aubagio | 6 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-bg-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cs-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-de-AT-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-de-BE-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-BE-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-hu-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-lt-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-nl-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-nl-BE-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pt-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-ro-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sk-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-sv-2023-503631-18 | 3 |
| Synopsis of the protocol (for publication) | d1-protocol-synopsis-trackchange-fr-2023-503631-18 | 1 |
| Synopsis of the protocol (for publication) | d1-rdct-protocol-synopsis-de-2023-503631-18 | 10 |
| Synopsis of the protocol (for publication) | d1-rdct-protocol-synopsis-fr-2023-503631-18 | 10 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-11 | Denmark | Acceptable with conditions 2024-05-06
|
2024-05-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-12 | Denmark | Acceptable with conditions 2024-05-06
|
2024-06-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Acceptable with conditions | 2024-07-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-24 | Acceptable with conditions | 2024-07-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-09 | Denmark | Acceptable 2024-11-28
|
2024-11-28 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-19 | Denmark | Acceptable 2024-11-28
|
2024-12-19 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-17 | Denmark | Acceptable 2024-11-28
|
2025-01-17 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-06 | Denmark | Acceptable 2025-05-08
|
2025-05-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-27 | Acceptable | 2025-07-07 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-24 | Acceptable | 2025-12-05 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-15 | Acceptable | 2025-11-11 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-05 | Denmark | Acceptable | 2025-12-05 |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-09 | Denmark | Acceptable 2026-03-27
|
2026-03-27 |