Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
381
Countries
9
Sites
31
Parkinson's disease
The primary objective of the study is to determine the effect of ND0612 on daily "ON" time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia) using subject-completed "ON/OFF" diary assessments of motor function in subjects with Parkinson's d…
Key facts
- Sponsor
- Neuroderm Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Feb 2020 → ongoing
- Decision date (initial)
- 2024-05-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511940-20-00
- EudraCT number
- 2018-004156-37
- ClinicalTrials.gov
- NCT04006210
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Efficacy
The primary objective of the study is to determine the effect of ND0612 on daily "ON" time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia) using subject-completed "ON/OFF" diary assessments of motor function in subjects with Parkinson's disease (PD) experiencing motor fluctuations.
Secondary objectives 1
- The key secondary objective of the study is to determine the effect of ND0612 on daily “OFF” time in subjects with PD experiencing motor fluctuations using subject-completed “ON/OFF” diary assessments of motor function. The other secondary objectives are to determine the effect of ND0612 on: • Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II (Motor Aspects of Experiences of Daily Living [M-EDL]). • Patient Global Impression of Change (PGIC). • Clinical Global Impression of Improvement (CGI-I). • MDS-UPDRS Part III (Motor Examination), measured in the “OFF” state or approximately 15 minutes before the next encapsulated oral dose (LD/CD or placebo). • Daily “ON” time without dyskinesia (troublesome or non-troublesome) using subject-completed “ON/OFF” diary assessments of motor function. • Proportion of responders in “OFF” time. • Parkinson’s disease Quality of Life (QoL) based on the 39-item PD Quality of Life questionnaire (PDQ-39). • The Parkinson’s Disease Sleep Scale (PDSS-2).
Conditions and MedDRA coding
Parkinson's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Study design 6 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Screening Period (1 to 4 weeks) Subjects will be assessed for study eligibility by the Investigator at the Screening Visit(s).
Screening procedures can be performed over a period of 28 days (the maximal interval between the Screening visit and the start of the IR-LD/CD Adjustment Period).
Subjects and study partners will be trained on the completion of “ON/OFF” diaries to describe the subjects’ motor state. Subjects and their study partners will be trained at home by clinical trial educators (CTEs) on the administration of the SC infusion using a training pump system. The CTE will train the site staff separately on the pump before the site can start recruiting. At the end of the Screening Period, the Investigator will assess the subject’s eligibility.
|
Not Applicable | Double | [{"id":170178,"code":5,"name":"Carer"},{"id":170177,"code":1,"name":"Subject"},{"id":170179,"code":4,"name":"Analyst"},{"id":170180,"code":2,"name":"Investigator"}] | |
| 2 | Open-Label Oral IR-LD/CD Adjustment Period (4 to 6 Weeks) The eligible subjects’ oral LD formulations and catechol-O-methyl transferase (COMT) inhibitor therapy will be converted to equivalent doses of oral IR-LD/CD 100/25 mg tablets. A subject’s oral IRLD/ CD dosage regimen will then be adjusted until the regimen is optimal, according to the Investigator’s judgement.
|
Not Applicable | None | ||
| 3 | Open-Label ND0612 Conversion Period (4 to 6 Weeks) Eligible subjects will receive treatment with ND0612 and adjunct grey encapsulated active oral 100/25 mg IR-LD/CD, as needed.
|
Not Applicable | None | ||
| 4 | Randomized, Double-Blind, Double-Dummy Maintenance Period (12 Weeks) Subjects will be randomized in a 1:1 ratio at the Randomization visit (V13/DB D1) to 1 of 2 treatment groups:
• Test Group (Group A): Active ND0612 infusion + placebo IR-LD/CD (white) + active IR-LD/CD (grey)
• Control Group (Group B): Active IR-LD/CD (white) + placebo infusion + placebo IR-LD/CD (grey)
|
Randomised Controlled | Double | [{"id":170184,"code":2,"name":"Investigator"},{"id":170186,"code":1,"name":"Subject"},{"id":170187,"code":4,"name":"Analyst"},{"id":170185,"code":5,"name":"Carer"}] | Paralel group: Subjects will be randomized in a 1:1 ratio at the Randomization visit (V13/DB D1) to 1 of 2 treatment groups: • Test Group (Group A): Active ND0612 infusion + placebo IR-LD/CD (white) + active IR-LD/CD (grey) • Control Group (Group B): Active IR-LD/CD (white) + placebo infusion + placebo IR-LD/CD (grey) |
| 5 | Optional Open-label Treatment Extension Period (up to 54 months) Subjects who completed the DBDD Maintenance Period will be offered the option to continue with open-label ND0612 treatment for up to 54 months in the open-label (OL) Treatment Extension Period. The end of the DBDD Maintenance Period will be defined as the first visit of the OL Treatment Extension Period. Oral LD/DDI tablets required for this period, as well as any other anti-PD medication, will not be provided by the Sponsor. Commercially available formulation/product will be
prescribed per the Investigator’s discretion.
|
Not Applicable | None | ||
| 6 | Safety Follow-up Period (4 Weeks) A safety follow-up visit will be performed 4 weeks after treatment completion (either after the DBDD Maintenance Period or after the OL Treatment Extension Period) or early treatment discontinuation. This follow-up visit is mandatory and is an in-person visit, except for subjects discontinuing treatment early during the Open-Label Oral IR-LD/CD Adjustment Period (for such subjects, the Investigator will determine whether the visit should be virtual or in-person). In case of an ongoing AE (including AESI), it will be followed-up until the event is resolved or until, in the opinion of the Investigator, the event is stabilized or determined to be chronic.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- Information was not required under CTD, to be determined.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2015-005814-31 | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease, Étude internationale, multicentrique, en ouvert, évaluant la sécurité du ND0612, une solution de lévodopa/carbidopa administrée en perfusion sous-cutanée continue à l'aide d'un système de pompe chez des patients présentant la maladie de Parkinson à un stade avancé (BeyoND), Étude internationale, multicentrique, en ouvert, évaluant la sécurité du ND0612, une solution de lévodopa/carbidopa administrée en perfusion sous-cutanée continue à l'aide d'un système de pompe chez des patients présentant la maladie de Parkinson à un stade avancé (BeyoND), Multicentrická, mezinárodní a otevřená studie ověřující bezpečnost přípravku ND0612, roztok levodopa-karbidopa, aplikovaný infuzní pumpou formou kontinuální subkutánní infuze u pacientů s pokročilou Parkinsonovou nemocí (BeyoND), Multicentrická, mezinárodní a otevřená studie ověřující bezpečnost přípravku ND0612, roztok levodopa-karbidopa, aplikovaný infuzní pumpou formou kontinuální subkutánní infuze u pacientů s pokročilou Parkinsonovou nemocí (BeyoND), Multicentrická, mezinárodní a otevřená studie ověřující bezpečnost přípravku ND0612, roztok levodopa-karbidopa, aplikovaný infuzní pumpou formou kontinuální subkutánní infuze u pacientů s pokročilou Parkinsonovou nemocí (BeyoND), Multicentrická, mezinárodní a otevřená studie ověřující bezpečnost přípravku ND0612, roztok levodopa-karbidopa, aplikovaný infuzní pumpou formou kontinuální subkutánní infuze u pacientů s pokročilou Parkinsonovou nemocí (BeyoND), Un estudio multicéntrico, internacional y abierto de la seguridad de ND0612, una solución de levodopa/carbidopa administrada mediante un sistema de bomba como perfusión subcutánea continua en sujetos con enfermedad de Parkinson avanzada (BeyoND), Studio multicentrico, internazionale, in aperto, volto a valutare la sicurezza di ND0612, una soluzione di levodopa/carbidopa somministrata tramite un sistema di infusione sottocutanea continua a pompa, in soggetti affetti da morbo di Parkinson in fase avanzata (BeyoND) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Male and female subjects with PD of any race at least 30 years of age who sign an Institutional Review Board/Ethics Committee–approved informed consent form (ICF).
- Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation); postmenopausal (defined as cessation of menses for at least 1 year); or willing to practice a highly effective method of contraception. All female subjects must be non-lactating and not pregnant and have a negative urine pregnancy test at Screening and at Enrollment (IR D1/ V2). Female subjects of childbearing potential must practice a highly effective method of contraception (such methods include combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation: oral / intravaginal; transdermal / progestogen-only hormonal contraception associated with inhibition of ovulation: oral / injectable; implantable / intrauterine device [IUD] / intrauterine hormone-releasing system [IUS]/ bilateral tubal occlusion / vasectomized partner/ sexual abstinence) from 1 month before Enrollment (IR D1/V2) until 1 month after the last dose of study treatment. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above.
- Subjects must have a named study partner that signed the ICF.
- Willingness and ability to comply with study requirements.
- Parkinson's disease diagnosis consistent with the UK Brain Bank Criteria.
- Modified Hoehn and Yahr scale in "ON" stage ≤ 3.
- Subjects must experience motor fluctuations and experience an average of at least 2.5 hours daily (with a minimum of 2 hours every day) in the "OFF" state during the waking hours as confirmed by an adequately completed "ON/OFF" diary over 3 days.
- Subject treatment should be at least 4 doses/day of LD/DDI (or at least 3 doses/day of extended release LD/DDI, e.g., Rytary) and at least 400 mg/day of LD, or equivalent according to the conversion table, and, according to the Investigator's judgement, the subject experiences motor fluctuations that cannot be further improved by adjusting anti-PD medications.
- Subjects and/or study partners have no impediment that may prevent them from operating the pump system.
- Subjects and/or study partners must demonstrate ability to keep accurate diary entries of PD symptoms ("ON/OFF" diaries) with at least 75% concordance with the Blinded Efficacy Rater by the end of the diary training session during the Screening Period, including at least 1 "OFF" assessment..
- Mini Mental State Examination (MMSE) score ≥ 24.
- Approval for entry into the study by an independent EAC.
Exclusion criteria 22
- Atypical or secondary Parkinsonism.
- Use of non-selective monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, tranylcypromine) within 4 weeks before enrollment.
- Subjects with severe disabling dyskinesias, based on Investigator's discretion.
- Current or previous diagnosis of Dopamine Dysregulation Syndrome.
- Subjects who answered "yes" to questions 4 or 5 of the C-SSRS within the last 5 years.
- Use of subcutaneous (SC) apomorphine injections, sublingual apomorphine, or inhaled LD within 4 weeks before the enrollment.
- Concomitant therapy or within 28 days before enrollment with: metoclopramide, reserpine, methylphenidate, or amphetamines, well as neuroleptics; exception in case of Quetiapine and Pimavanserin use: (1) allowed only in case it had been used for a period of at least 3 months before enrollment, (2) subject is on stable therapy for at least 3 months (3) underlying psychosis to be under control and anticipating no changes to the dosage of the medication throughout the study.
- Subjects who have previously undergone treatment for PD with a surgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures, gene therapy), Duodopa®/Duopa®, or continuous dopaminergic or apomorphine infusion. Subjects who have discontinued Duodopa®/Duopa® treatment at least 6 months before enrollment and have undergone stoma closure surgery at least 6 months before enrollment, may be included in this study. Subjects who are planning to undergo treatment for PD with a surgical intervention will be enrolled at the Investigator's discretion.
- Subjects with a history of alcohol or substance abuse within the past 12 months.
- Subjects who do not have sufficient SC tissue for SC infusion treatment.
- Subjects who have previously participated in studies ND0612H-006 and/or ND0612H-012.
- Use of monoamine-depleting agents (e.g., reserpine, tetrabenazine, deutetrabenazine, valbenazine, xenazine) within 4 weeks before enrollment.
- Subjects who have taken experimental medications within 30 days before enrollment.
- Known allergy to the study drug or placebo or any of their excipients.
- Impulse control disorder within the past 2 years, if considered clinically significant by the investigator.
- Acute psychosis or troublesome hallucinations in the past 6 months.
- Subjects with clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry, or potentially unable to complete all aspects of the study.
- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of different lesions (e.g., sunburn, acne, scar tissue, tattoo, open wound, branding, or pigmentation) that, in the Investigator's opinion, would interfere with the infusion of the study drug or could interfere with study assessments.
- Clinically significant ECG abnormalities.
- Renal or liver dysfunction that may alter drug metabolism including Screening Visit serum levels of creatinine > 1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal, and total bilirubin > 2.5 mg/dL.
- Any malignancy in the 5 years before enrollment, except basal cell carcinoma of the skin, squamous cell carcinoma in situ, or cervical carcinoma in situ that have been successfully treated.
- Subjects with narrow angle glaucoma.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the change from Baseline to the end of the DBDD Maintenance Period in the mean daily "ON" time without troublesome dyskinesia adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visit.
Secondary endpoints 1
- The key secondary efficacy endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean daily "OFF" time adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's "ON/OFF" diary assessments on the 3 consecutive days before the visits.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD3503373 · Product
- Active substance
- Carbidopa
- Pharmaceutical form
- SOLUTION FOR INFUSION IN ADMINISTRATION SYSTEM
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 720 mg milligram(s)
- Max total dose
- 1261310 mg milligram(s)
- Max treatment duration
- 59 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- NEURODERM LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
PRD11188439 · Product
- Active substance
- Carbidopa
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NEURODERM LTD
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 3
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
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
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neuroderm Ltd.
- Sponsor organisation
- Neuroderm Ltd.
- Address
- Bell Entrance, Floor 4, 3, Pekeris Street Floor 4 3, Pekeris Street
- City
- Rehovot
- Postcode
- 7670212
- Country
- Israel
Scientific contact point
- Organisation
- Neuroderm Ltd.
- Contact name
- Scientific contact, Public Contact
Public contact point
- Organisation
- Neuroderm Ltd.
- Contact name
- Scientific contact, Public Contact
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Taxi Travel Ticket S.L. ORG-100042292
|
Barcelona, Spain | Other |
| Novasco ORG-100046671
|
Paris, France | Other |
| MARKEN Germany GmbH ORG-100017196
|
Kelsterbach, Germany | Other |
| WCG Clinical Inc. ORG-100040730
|
Los Angeles, United States | Code 8 |
| Emsere B.V. ORG-100046660
|
Leiden, Netherlands | Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 11, Code 12, Code 2, Data management, E-data capture, Code 8 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
9 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 3 | 1 |
| Belgium | Ended | 2 | 1 |
| Czechia | Ended | 2 | 1 |
| France | Ended | 11 | 7 |
| Italy | Ongoing, recruitment ended | 41 | 7 |
| Poland | Ended | 20 | 3 |
| Portugal | Ended | 18 | 2 |
| Slovakia | Ongoing, recruitment ended | 4 | 1 |
| Spain | Ongoing, recruitment ended | 55 | 8 |
| Rest of world
Israel, United Kingdom, United States, Ukraine, Russian Federation
|
— | 225 | — |
Investigational sites
Medizinische Universitaet Innsbruck
University Hospital for Neurology, Anichstrasse 35, 6020, Innsbruck
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Neurology, Avenue Max Buset 34, 7100, La Louviere
University Hospital Of Clermont-Ferrand
Service de Neurologie, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire De Nice
Service de neurologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Nantes
Unite d’Investigation Clinique (UIC) - neurologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Nimes
Service de Neurologie, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Hospices Civils De Lyon
Hopital de jour recherche (Unite 502 - Recherche), 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Regional De Marseille
264 rue Saint Pierre, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Toulouse
Centre d’Investigation Clinique Service de Neurologie B8, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Dipartimento di Scienze Mediche e Chirurgiche Avanzate (DAMSS) - Università degli studi della Campan, Piazza Luigi Miraglia 2, 80138, Naples
Irccs San Raffaele Roma S.r.l.
San Raffaele Cassino - Parkinson Disease Center, Via Gaetano Di Biasio 1, 03043, Cassino
Humanitas Mirasole S.p.A.
U.O Neurologia I, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda USL Toscana Sud Est
Ospedale della Misericordia, UOC Neurologia, Via Senese 169, 58100, Grosseto
Irccs San Raffaele Roma S.r.l.
Department of Neurology – Clinical Trial Center, Via Della Pisana 235, 00163, Rome
Universita' Degli Studi G. D'annunzio Di Chieti
Department of Neuroscience, Imaging and Medical Sciences, Via Luigi Polacchi 11, 66100, Chieti Scalo
Fondazione Santa Lucia IRCCS
Laboratory of Neuropsychiatry - Department of Clinical and Behavioral Neurology, Via Ardeatina 306, 00179, Rome
Krakowska Akademia Neurologii Sp. z o.o.
Not applicable, Ul. Arianska 7/3, 31-505, Cracow
Neuro-Care Sp. z o.o. sp.k.
Not applicable, Ul. Pawla Kolodzieja 8, 40-749, Katowice
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Not applicable, Ul. Andrzeja Struga 49/51, 90-640, Lodz
CNS Saude Lda.
Neurology, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
CCAB Centro Clinico Academico Braga Associacao
Hospital Braga, Lugar De Sete Fontes S Victor, 4710-243, Braga
University Hospital Bratislava
II. Neurologicka klinika LF UK a UNB, Limbova 5, Nove Mesto, Bratislava
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario De La Princesa
Neurology, Calle De Diego De Leon 62, 28006, Madrid
Hospital General Universitario De Elche
Neurology, Edificio 2, Camino De La Almazara 11, Elche
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 | 2020-05-26 | 2026-01-08 | 2020-11-27 | 2022-04-11 | |
| Belgium | 2020-06-17 | 2025-11-17 | 2021-01-11 | 2022-04-11 | |
| Czechia | 2020-02-28 | 2025-10-08 | 2020-07-16 | 2022-04-11 | |
| France | 2020-05-29 | 2026-04-10 | 2020-09-09 | 2022-04-11 | |
| Italy | 2020-05-26 | 2020-08-04 | 2022-04-11 | ||
| Poland | 2020-02-05 | 2025-10-13 | 2020-02-25 | 2022-04-11 | |
| Portugal | 2020-08-13 | 2025-09-02 | 2020-10-20 | 2022-04-11 | |
| Slovakia | 2020-08-04 | 2021-08-12 | 2022-04-11 | ||
| Spain | 2020-02-17 | 2020-05-26 | 2022-04-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 51 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511940-20-00_Redacted | 3.1 |
| Recruitment arrangements (for publication) | K1_Blank document | NA |
| Recruitment arrangements (for publication) | K1_Blank document | NA |
| Recruitment arrangements (for publication) | K1_Blank document | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_Blank document | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PT_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Partner_PT_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PGx_PT_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_PT_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ES_Redacted | 9.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_DUT_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_ENG_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_FRE_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx SubStudy ICF_ES_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx Substudy_FR_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_BE_DUT_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_BE_ENG_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_BE_FRE_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP-birth data collection_FR_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_ES_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_DUT_Redacted | V2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_ENG_Redacted | V2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_FRE_Redacted | V2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Principal_FR_Redacted | 9.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner ICF_ES_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_BE_DUT_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_BE_ENG_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_BE_FRE_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_FR_Redacted | 5.1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_ES_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_FR_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_IT_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_PL_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_Placeholder_AT | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_Placeholder_BE | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_Placeholder_CZ | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_PT_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511940-20-00_SK_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_DUT_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_FRE_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_GER_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_FRE_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2024-511940-20-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2024-511940-20-00 | 1.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-26 | Poland | Acceptable 2024-05-17
|
2024-05-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-04 | Poland | Acceptable 2024-10-14
|
2024-10-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-18 | Acceptable 2024-10-14
|
2024-12-18 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-28 | Poland | Acceptable 2024-10-14
|
2025-01-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-04 | Poland | Acceptable 2025-10-10
|
2025-10-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-04 | Acceptable | 2025-11-17 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-02 | Acceptable | 2026-03-02 |