Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
520
Countries
9
Sites
71
Chronic and Episodic Migraine
To evaluate the tolerability and safety of atogepant compared to the highest tolerated dose of topiramate in participants who require preventive treatment of migraine.
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Jan 2024 → ongoing
- Decision date (initial)
- 2023-09-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501172-25-00
- ClinicalTrials.gov
- NCT05748483
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Prophylaxis
To evaluate the tolerability and safety of atogepant compared to the highest tolerated dose of topiramate in participants who require preventive treatment of migraine.
Secondary objectives 1
- To demonstrate a higher rate of participants treated with atogepant versus topiramate achieving >= 50% improvement (reduction) in mean monthly migraine days (MMDs) during Months 4 to 6 of the Double Blind treatment period.
Conditions and MedDRA coding
Chronic and Episodic Migraine
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10052787 | Migraine without aura | 100000004852 |
| 20.0 | PT | 10058734 | Migraine prophylaxis | 100000004865 |
| 20.0 | PT | 10027607 | Migraine with aura | 100000004852 |
| 21.1 | LLT | 10066636 | Chronic migraine | 10029205 |
| 22.0 | LLT | 10082019 | Episodic migraine | 10029205 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening/Baseline Period A 4-5 week period after consent and screening procedures when headache data is collected by the patient but no study treatment is provided
|
Not Applicable | None | Screening/Baseline Period: A 4-5 week period after consent and screening procedures when headache data is collected by the patient but no study treatment is provided | |
| 2 | Double-Blind Treatment Period A 24-week double-blind (DB) treatment period where subjects will be randomized in a 1:1 ratio to receive atogepant or topiramate, including a topiramate up-titration phase (6 weeks) and maintenance phase (18 weeks).
|
Randomised Controlled | Double | [{"id":167042,"code":4,"name":"Analyst"},{"id":167040,"code":2,"name":"Investigator"},{"id":167039,"code":3,"name":"Monitor"},{"id":167041,"code":1,"name":"Subject"}] | Atogepant: Participants will receive atogepant (and placebo for topiramate) during the DB period. Topiramate: Participants will receive topiramate (and placebo for atogepant) during the DB period. |
| 3 | Open Label Treatment Period A 52-week open label treament period where eligibile participants will receive atogepant.
|
Not Applicable | None | Atogepant: Atogepant will be taken orally QD until visit 18/week 76. | |
| 4 | Safety Follow-Up Period A safety follow-up period (4 weeks) where no study treatment is given
|
Not Applicable | None | Safety Follow-up Period: A safety follow-up period (4 weeks) where no study treatment is given |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Documented history of migraine (with or without aura) for >= 12 months prior to screening (Visit 1)
- History of >= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis.
Exclusion criteria 2
- Have used topiramate or atogepant in the past.
- Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period
Secondary endpoints 6
- Achievement of ≥ 50% improvement (reduction) in mean MMD during Months 4 to 6 of the DB treatment period.
- Change from baseline in mean MMD during Months 4 to 6 of the DB treatment period
- Change from baseline in HIT-6 total score at Week 24
- Change from baseline in MSQ Version 2.1 RFR domain score at Week 24
- Achievement of a rating of "much better" or "very much better" at Week 24 assessed by the PGIC
- Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function –Abilities Subset –Short Form 6a Version 2.0 score at Week 6
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9649619 · Product
- Active substance
- Atogepant
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 31920 mg milligram(s)
- Max treatment duration
- 76 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALLERGAN SALES, LLC (A SUBSIDIARY OF ABBVIE INC.)
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
SUB11190MIG · Substance
- Active substance
- Topiramate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 16100 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Tablets of topiramate 25mg are over-encapsulated to create capsules of topiramate 25mg - Grey opaque unmarked capsules.
SUB11190MIG · Substance
- Active substance
- Topiramate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 16100 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Tablets of topiramate 25mg are over-encapsulated to create capsules of topiramate 50mg - Grey opaque unmarked capsules.
Placebo 2
Placebo for atogepant tablets 60mg
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
Placebo for topiramate capsules 25mg and 50mg
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
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Autocruitment LLC ORG-100042205
|
Atlanta, United States | Code 2 |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Signant Health Inc. ORG-100040732
|
Blue Bell, United States | Other, E-data capture |
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| Abbvie Bioresearch Center Inc. ORG-100011500
|
North Chicago, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Raleigh, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
Locations
9 EU/EEA countries · 71 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 3 |
| Belgium | Ongoing, recruitment ended | 30 | 5 |
| Czechia | Ended | 75 | 10 |
| France | Ended | 12 | 3 |
| Germany | Ended | 170 | 22 |
| Hungary | Ended | 30 | 7 |
| Italy | Ended | 32 | 6 |
| Poland | Ended | 75 | 9 |
| Portugal | Ended | 45 | 6 |
| Rest of world
United Kingdom, Israel, Canada
|
— | 45 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Department of Neurology, Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Department of Neurology, Waehringer Guertel 18-20, Alsergrund, Vienna
Konvent Der Barmherzigen Brueder
Department of Neurogeriatric Medicine, Seilerstätte 2, 4020, Linz
Universitair Ziekenhuis Gent
N/A, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Regional De La Citadelle
N/A, Bld Du Douzieme-De-Ligne 1, 4000, Liege
UZ Brussel
N/A, Laarbeeklaan 101, 1090, Jette
Jessa Ziekenhuis
N/A, Stadsomvaart 11, 3500, Hasselt
Az St-Jan Brugge-Oostende A.V.
N/A, Ruddershove 10, 8000, Brugge
Praglandia s.r.o.
n/a, Ostrovskeho 253/3, Smichov, Prague 5
Clintrial s.r.o.
n/a, Pocernicka 1427/16, Strasnice, Prague 10
Fakultni Thomayerova nemocnice
n/a, Videnska 800, Krc, Prague 4
Pratia Pardubice a.s.
n/a, Trida Miru 2800, Zelene Predmesti, Pardubice I
A-Shine s.r.o.
n/a, Sumavska 2, Vychodni Predmesti, Plzen 3
Neurohk s.r.o.
n/a, Smetanova 830, 565 01, Chocen
INEP medical s.r.o.
n/a, Soubezna II 664 29, 158 00, Prague 5
CCR Prague s.r.o.
n/a, Vinohradska 1597/174, Vinohrady, Prague 3
Praglandia s.r.o.
n/a, Nadrazni 3368/30a, Smichov, Prague
CCR Ostrava s.r.o.
n/a, 28. Rijna 3348/65, Moravska Ostrava, Moravska Ostrava A Privoz
CHU Gabriel-Montpied
n/a, 58 Rue Montalembert, 63000, Clermont Ferrand
Assistance Publique Hopitaux De Paris
n/a, 2 Rue Ambroise Pare, 75010, Paris
Hospital Pierre Wertheimer
n/a, 59 Boulevard Pinel, 69500, Bron
Pharmakologisches Studienzentrum Chemnitz GmbH
N/A, Carolastrasse 2, Zentrum, Chemnitz
Charite Universitatsmedizin Berlin KöR
N/A, Charitéplatz 1, Mitte, Berlin
Neuropraxis Muenchen Sued
N/A, Hauptstrasse 2, 82008, Unterhaching
Gesundheitszentrum Hoppegarten
N/A, Lindenallee 7, 15366, Hoppegarten
Kopfschmerzzentrum Frankfurt
N/A, Dalbergstr. 2, 65929, Frankfurt am Main
Schmerzklinik Kiel Gmbh & Co. KG Klinik Fuer neurologisch-verhaltensmedizinische Schmerztherapie
N/A, Heikendorfer Weg 9-27, Neumuehlen-Dietrichsdorf, Kiel
Zentrum fuer klinische Forschung Dr. Schoell
n/a, Hessenring 121, 61348, Bad Homburg
Technische Universitat Dresden
N/A, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Neurologisches Facharztzentrum Berlin
N/A, Paretzer Str. 12, 10713, Berlin
University Medicine Greifswald
N/A, Ferdinand Sauerbruch Strasse, 17475, Greifswald
Klinische Forschung Schwerin GmbH
N/A, Friedrichstrasse 1, Altstadt, Schwerin
NeuroZentrum Bielefeld
N/A, Hauptstr. 102, 33647, Bielefeld
Klinische Forschung Hannover-Mitte GmbH
N/A, Schillerstrasse 30, Mitte, Hanover
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
N/A, Weidenauer Strasse 120, Weidenau, Siegen
Klinische Forschung Hamburg GmbH
N/A, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
Universitaetsklinikum Tuebingen
N/A, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Neuro Centrum Science GmbH
N/A, Albert-Schweitzer-Strasse 8, 64711, Erbach
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Universitaetsklinikum Essen AöR
N/A, Hufelandstrasse 55, Holsterhausen, Essen
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
N/A, Muensterplatz 32, Mitte, Ulm
Dr. Med Joachim Springub Facharzt Fur Neurologie U Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt Fur Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
N/A, Lange Strasse 25, 26655, Westerstede
Studienzentrum Dr. Bischof GmbH
N/A, Konrad-Zuse-Strasse 14, West, Boeblingen
Semmelweis University
n/a, Bokay Janos Utca 53, 1083, Budapest VIII
University Of Debrecen
n/a, Moricz Zsigmond Korut 22, 4032, Debrecen
Mind Klinika Kft.
n/a, Lovohaz utca 39, 1024, Budapest
Clinexpert Kft.
n/a, Kaszasdulo Utca 5, 1033, Budapest III
Semmelweis University
Tuzolto utcai Reszleg, Tuzolto Utca 7-9, 1094, Budapest
DRC Kft.
n/a, Ady Endre Utca 12/b, 8230, Balatonfured
S-Medicon Kft.
n/a, Megyeri Ut 53, 1044, Budapest IV
Fondazione Policlinico Universitario Campus Bio-Medico
n/a, Via Alvaro Del Portillo N 200, 00128, Rome
Careggi University Hospital
n/a, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Neurological Institute Foundation Casimiro Mondino
n/a, Via Casimiro Mondino 2, 27100, Pavia
Azienda Ospedaliero Universitaria Di Modena
n/a, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria - Universita' Degli Studi Della Campania Luigi Vanvitelli
n/a, Piazza Luigi Miraglia 2, 80138, Naples
Irccs San Raffaele Roma S.r.l.
N/A, Via Di Val Cannuta 250, 00166, Rome
Vitamed Galaj I Cichomski Sp. j.
N/A, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Rcmed Oddzial Sochaczew
N/A, Aleja 600-Lecia 45, 96-500, Sochaczew
Silmedic Sp. z o.o.
N/A, Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
Solumed Sp. z o.o. S.K.
N/A, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Clinical Research Center Sp. z o.o. Medic-R sp.k.
N/A, Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Etg Neuroscience Sp. z o.o.
N/A, Ul. Wynalazek 4, 02-677, Warsaw
Athleticomed Sp. z o.o.
N/A, Ul. Fordonska 144, 85-752, Bydgoszcz
Indywidualna Praktyka Lekarska Dr hab. med. Anna Szczepanska-Szerej
N/A, Ul. Onyksowa 12, 20-582, Lublin
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. sp. k.
N/A, Ul Gen Jaroslawa Dabrowskiego 4, 32-600, Oswiecim
CCAB Centro Clinico Academico Braga Associacao
n/a, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Matosinhos E.P.E.
n/a, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Hospital Professor Doutor Fernando Fonseca E.P.E.
n/a, Itinerario Complementar 19 Acesso Ao Hospital 19, 2720-276, Amadora
Hospital Garcia De Orta E.P.E.
n/a, Avenida Torrado Da Silva, 2801-951, Almada
Hospital De Santa Maria E.P.E.
n/a, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Hospital Da Luz S.A.
n/a, Avenida Lusiada 100, 1500-650, Lisbon
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 | 2023-11-07 | 2026-03-03 | 2024-02-21 | 2024-10-02 | |
| Belgium | 2023-10-12 | 2023-10-13 | 2024-10-02 | ||
| Czechia | 2023-10-31 | 2026-05-12 | 2023-11-13 | 2024-10-02 | |
| France | 2023-10-20 | 2026-05-04 | 2023-11-08 | 2024-10-02 | |
| Germany | 2023-10-06 | 2026-05-21 | 2023-11-03 | 2024-10-02 | |
| Hungary | 2023-10-25 | 2026-05-11 | 2023-11-14 | 2024-10-02 | |
| Italy | 2023-10-23 | 2026-05-07 | 2023-11-07 | 2024-10-02 | |
| Poland | 2023-10-09 | 2026-05-19 | 2023-10-17 | 2024-10-02 | |
| Portugal | 2023-10-11 | 2026-06-02 | 2023-11-02 | 2024-10-02 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 9 · Art. 38 CTR
Temporary halt TH-10593
- Halt date
- 2023-12-23
- Member states concerned
- Hungary
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10591
- Halt date
- 2023-12-23
- Member states concerned
- Germany
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10589
- Halt date
- 2023-12-23
- Member states concerned
- France
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10587
- Halt date
- 2023-12-23
- Member states concerned
- Czechia
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10599
- Halt date
- 2023-12-23
- Member states concerned
- Poland
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10585
- Halt date
- 2023-12-23
- Member states concerned
- Belgium
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10597
- Halt date
- 2023-12-23
- Member states concerned
- Portugal
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10595
- Halt date
- 2023-12-23
- Member states concerned
- Italy
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-10584
- Halt date
- 2023-12-23
- Member states concerned
- Austria
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Please find enclosed a notification of a temporary halt to recruitment only.
AbbVie is implementing this due to a temporary shortage of Investigational Product supply for Topiramate, used as comparator in the trial.
While there is Topiramate supply available for all subjects currently in screening and randomization, to avoid running out of topiramate for future subjects, the decision was made to pause screening. Screening will be on hold starting 23 December 2023 and will continue until February 2024 when adequate drug supply is expected to be available. This hold is not related to any concerns to subject safety.
A Dear Investigator Letter has been distributed to active sites on December 18th 2023, detailing the modalities of this screening pause, as well as to sites that are not yet active on December 19th 2023. - Follow-up measures
- Screening Hold Impact to Enrolled Subjects:
- Subjects randomized in the study will have no interruption in study drug supply.
- Subjects in screening can randomize and will have no interruption to study drug supply.
- Subjects who have screen failed and may be rescreened in accordance with the protocol will be assessed by the Sponsor on a case-by-case basis to ensure sufficient supply of topiramate. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-DE-0001
- Member state
- Germany
- Publication date
- 2024-06-27
- Type
- 4
- Reason
- 5
- Immediate action required
- No
- Justification
- associated notification: ad hoc assessment FR-0000000010;
Justification: New identified risk
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 112 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m22061-protocol-redacted | 5.0 |
| Protocol (for publication) | D4_m22061-Patient facing documents-HIT-6-public | 1.0 |
| Protocol (for publication) | D4_m22061-Patient facing documents-MSQ-public | 2.1 |
| Protocol (for publication) | D4_m22061-Patient facing documents-PGIC-public | 1.0 |
| Protocol (for publication) | D4_m22061-Patient facing documents-PROMIS SF-6a-public | 2.0 |
| Recruitment arrangements (for publication) | M22-061 ad and recruitment material - Physician Refferal Letter AT_public | 2 |
| Recruitment arrangements (for publication) | M22-061 AT AutoCruitment Digital Materials_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 AT AutoCruitment Impressum Website page_Public redacted | 1 |
| Recruitment arrangements (for publication) | M22-061 AT AutoCruitment Phone Screening Script_Public | 6 |
| Recruitment arrangements (for publication) | M22-061 AT Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | M22-061 AutoCruitment Website Design_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 BE Flyer Dutch_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Flyer English_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Flyer French_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Physican Referall Letter English_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Physician Referall Letter Dutch_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Physician Referall Letter French_public | 1 |
| Recruitment arrangements (for publication) | M22-061 BE Recruitment and ICF Procedure_public | 2 |
| Recruitment arrangements (for publication) | M22-061 CZ AutoCruitment Digital Materials_Public | 6 |
| Recruitment arrangements (for publication) | M22-061 CZ AutoCruitment Phone Screening Script_Public | 6 |
| Recruitment arrangements (for publication) | M22-061 CZ AutoCruitment Website Design_Public | 6 |
| Recruitment arrangements (for publication) | M22-061 DE Ad and Recruit AutoCruitment Digital Materials_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 DE Ad and Recruit AutoCruitment Impressum Website page_Public | 1 |
| Recruitment arrangements (for publication) | M22-061 DE Ad and Recruit AutoCruitment Phone Screening Script_Public | 6 |
| Recruitment arrangements (for publication) | M22-061 DE Ad and Recruitment AutoCruitment Website Design_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 DE ad and recruitment material - Physician Referral Letter_public | 2 |
| Recruitment arrangements (for publication) | M22-061 FR - Ad and Recruitment Materials - French - public | 1 |
| Recruitment arrangements (for publication) | M22-061 FR Branded Flyer_public | 1 |
| Recruitment arrangements (for publication) | M22-061 IT Ad and Recruitment Digital Materials_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 IT Ad and Recruitment Phone Screening Script_Public | 9 |
| Recruitment arrangements (for publication) | M22-061 IT Ad and Recruitment Website Design_Public | 7 |
| Recruitment arrangements (for publication) | M22-061 IT Branded Flyer_public | 1 |
| Recruitment arrangements (for publication) | M22-061 IT Recruitment and ICF Procedure_public | 2.0 |
| Recruitment arrangements (for publication) | M22-061 Physician Referral Letter Polish_public | 1 |
| Recruitment arrangements (for publication) | M22-061 Physician Referral Letter_English_public | 3 |
| Recruitment arrangements (for publication) | M22-061 Physician Referral Letter_English_public | 2.0 |
| Recruitment arrangements (for publication) | M22-061 PL AutoCruitment Digital Materials_public | 6 |
| Recruitment arrangements (for publication) | M22-061 PL AutoCruitment Phone Screening Script_public | 7 |
| Recruitment arrangements (for publication) | M22-061 PL AutoCruitment Website Design_public | 6 |
| Recruitment arrangements (for publication) | M22-061 PL Branded Flyer_public | 1 |
| Recruitment arrangements (for publication) | M22-061 Recruit Material Site Stahl_public | 1 |
| Recruitment arrangements (for publication) | M22-061_AT_Flyer_public | 1.0 |
| Recruitment arrangements (for publication) | M22-061_CZ_Patient Flyer_public | 1 |
| Recruitment arrangements (for publication) | M22-061_CZ_Recruitment and Informed consent procedure_public | 2 |
| Recruitment arrangements (for publication) | M22-061_DE-ad and recruitment material-flyer_public | 1 |
| Recruitment arrangements (for publication) | M22-061_FR Recruitment and ICF Procedure_public | 2 |
| Recruitment arrangements (for publication) | M22-061_Migrane_flyer_poster_print_ad_kfgn_Deckert_Gade_Paschen_public | 4 |
| Recruitment arrangements (for publication) | M22-061_Migrane_landingpage_kfgn_Deckert_Gade_Paschen_public | 4 |
| Recruitment arrangements (for publication) | M22-061_Migrane_patientletter_database_kfgn_Deckert_Gade_Paschen_public | 4 |
| Recruitment arrangements (for publication) | M22-061_PL_Recruitment and ICF Procedures_public | 2 |
| Recruitment arrangements (for publication) | M22-061_PT_ Recruitment and Informed Consent Procedure_public | 2 |
| Recruitment arrangements (for publication) | M22-061_PT_Referral Letter_public | 1 |
| Recruitment arrangements (for publication) | M22-061_PT-Patient_flyer_public | 2 |
| Recruitment arrangements (for publication) | M22-061_Recruitment and ICF Procedure_public | 2 |
| Recruitment arrangements (for publication) | M22-061_Recruitment and Informed Consent Procedure_public | 2.0 |
| Recruitment arrangements (for publication) | M22-061_Recruitment Flyer_HUN_public | 2.0 |
| Recruitment arrangements (for publication) | M22-061- IT_Physician Referral Letter_public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-061 CZ Main ICF_Public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-061 FR ICF Addendum_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M22-061 AT ICF Main_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 AT ICF Optional Research_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 BE Main ICF Dutch_public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-061 BE Main ICF English_ public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-061 BE Main ICF French_public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-061 CZ Privacy ICF_clean | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 CZ_ICF Optional_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M22-061 DE Main ICF_German_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 FR ICF Main_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 HU_Main PIS_ICF_clean_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 IT ICF Main_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-061 PL ICF MAIN_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M22-061 PT Combined ICF Main and Optional_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_M22-061_HU_List of sites with OMS_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | M22-061 - HU List of ICFs_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 AT ICF PregPart_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 AT Site Contact List_public redacted | 1.2 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF Biomarker Study Dutch_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF Biomarker Study English_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF Biomarker Study French_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF PK Substudy Dutch_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF PK Substudy English_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 BE Optional ICF PK Substudy French_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 BE PregPart ICF Dutch_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 BE PregPart ICF English_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 BE PregPart ICF French_public | 2 |
| Subject information and informed consent form (for publication) | M22-061 CZ - ICF PregPart_public | 2.0 |
| Subject information and informed consent form (for publication) | M22-061 IT - ICF Other Country Sample Italian_public | 1 |
| Subject information and informed consent form (for publication) | M22-061 IT ICF pregnancy_Clean_public | 2.0 |
| Subject information and informed consent form (for publication) | M22-061_CZ_COVID-19 Patient Information Sheet czech_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_DE-ICF Other Optional_public | 1.1 |
| Subject information and informed consent form (for publication) | M22-061_DE-ICF PregPart_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_FR_ICF PregPart_public | 2.1 |
| Subject information and informed consent form (for publication) | M22-061_HU_Description of ICFs_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_HU_Optional Genetic ICF_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_HU_Optional Genetic PIS_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_HU_Pregnant Partner Authorization and ICF_public | 2 |
| Subject information and informed consent form (for publication) | M22-061_PL_ICF Authorization for Pregnancy Data Release version_public | 2 |
| Subject information and informed consent form (for publication) | M22-061_PL_ICF OPTIONAL_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_PT-ICF Optional PK_public | 1 |
| Subject information and informed consent form (for publication) | M22-061_PT-ICF PregPart_public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Topiramate-25mg-filmcoated tablets | n/a |
| Synopsis of the protocol (for publication) | D1_ m22061-protocol-synopsis-DE-AT | 5.0 |
| Synopsis of the protocol (for publication) | D1_ m22061-protocol-synopsis-FR-FR | 5.0 |
| Synopsis of the protocol (for publication) | D1_ m22061-protocol-synopsis-HU-HU | 5.0 |
| Synopsis of the protocol (for publication) | D1_ m22061-protocol-synopsis-IT-IT | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis_PT-PT | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis-CS-CZ | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis-DE-BE | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis-FR-BE | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis-NL-BE | 5.0 |
| Synopsis of the protocol (for publication) | D1_m22061-protocol-synopsis-PL-PL | 5.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-19 | Germany | Acceptable 2023-09-07
|
2023-09-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-12 | Germany | Acceptable 2024-03-15
|
2024-03-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-20 | Germany | Acceptable 2024-08-19
|
2024-08-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-25 | Acceptable 2024-08-19
|
2024-09-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-30 | Germany | Acceptable 2025-02-07
|
2025-02-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-22 | Germany | Acceptable 2025-07-02
|
2025-07-03 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-10 | Acceptable | 2025-12-18 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-19 | Acceptable | 2026-01-19 |