Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
596
Countries
9
Sites
55
Chronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine)
To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 156 weeks for the prevention of migraine in participants with CM or EM
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
- 16 Aug 2021 → 20 Oct 2025
- Decision date (initial)
- 2023-12-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-507096-21-00
- EudraCT number
- 2020-002470-27
- ClinicalTrials.gov
- NCT04686136
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Prophylaxis, Efficacy
To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 156 weeks for the prevention of migraine in participants with CM or EM
Conditions and MedDRA coding
Chronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027607 | Migraine with aura | 100000004852 |
| 20.0 | HLT | 10027603 | Migraine headaches | 10029205 |
| 21.1 | LLT | 10066636 | Chronic migraine | 10029205 |
| 20.0 | PT | 10052787 | Migraine without aura | 100000004852 |
| 22.0 | LLT | 10082019 | Episodic migraine | 10029205 |
| 20.0 | PT | 10027599 | Migraine | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
Exclusion criteria 5
- Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
- Participants with an ECG indicating clinically significant abnormalities at Visit 1
- Participants with hypertension at Visit 1
- Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Secondary endpoints 4
- Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
- Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
- Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
- Percentage of Participants with Clinically Significant Laboratory values, ECG findings or Vital Sign measures as assessed by Investigator; and results of the CSSRS Scale.
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
- 65520 mg milligram(s)
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALLERGAN SALES, LLC (A SUBSIDIARY OF ABBVIE INC.)
- Paediatric formulation
- No
- Orphan designation
- 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 |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| National Medical Services Inc. ORG-100046029
|
Horsham, United States | Other |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other |
| Labcorp ORG-100011514
|
Burlington, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Eurofins Viracor Biopharma Services Inc. ORG-100041736
|
Lenexa, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
Locations
9 EU/EEA countries · 55 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 205 | 13 |
| Denmark | Ended | 3 | 1 |
| France | Ended | 8 | 5 |
| Germany | Ended | 38 | 12 |
| Hungary | Ended | 12 | 4 |
| Italy | Ended | 24 | 6 |
| Netherlands | Ended | 6 | 2 |
| Poland | Ended | 78 | 9 |
| Spain | Ended | 8 | 3 |
| Rest of world
United States, Canada, United Kingdom, Korea, Republic of, Taiwan
|
— | 214 | — |
Investigational sites
CCR Ostrava s.r.o.
N/A, 28. Rijna 3348/65, Moravska Ostrava, Moravska Ostrava A Privoz
Forbeli s.r.o.
N/A, Kolejni 429/5 Dejvice, 160 00, Prague
Pratia Prague s.r.o.
N/A, Vinohradska 1597/174, Vinohrady, Prague 3
INEP medical s.r.o.
N/A, Krizikova 264/22, Karlin, Prague
Brain-Soultherapy s.r.o.
N/A, K Nemocnici 1904, 272 01, Kladno
Dado Medical s.r.o.
N/A, Budecska 2165/33, Vinohrady, Prague
Pratia Pardubice a.s.
N/A, Trida Miru 2800, Zelene Predmesti, Pardubice I
Fakultni Thomayerova nemocnice
N/A, Videnska 800, Krc, Prague 4
A-Shine s.r.o.
N/A, Sumavska 2, Vychodni Predmesti, Plzen 3
Neurohk s.r.o.
N/A, Smetanova 830, 565 01, Chocen
NeuroMed Zlin s.r.o.
N/A, Koterova 5546, 760 01, Zlin
Vestra Clinics s.r.o.
N/A, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
Clintrial s.r.o.
N/A, Pocernicka 1427/16, Strasnice, Prague 10
CHU Gabriel-Montpied
N/A, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Universitaire De Nice
N/A, 4 Avenue Reine Victoria, 06000, Nice
Centre Hospitalier Universitaire De Saint Etienne
N/A, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Assistance Publique Hopitaux De Marseille
N/A, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
N/A, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
University Hospital Jena KöR
N/A, Am Klinikum 1, Lobeda, Jena
Praxis Dr. Gendolla
N/A, Am Alfredusbad 2, 45133, Essen
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
N/A, Muensterplatz 32, Mitte, Ulm
Universitaetsklinikum Essen AöR
N/A, Hufelandstrasse 55, Holsterhausen, Essen
Charite Universitaetsmedizin Berlin KöR
N/A, Chariteplatz 1, Mitte, Berlin
Vitos Orthopaedische Klinik Kassel gGmbH
N/A, Wilhelmshoeher Allee 345, Wilhelmshoehe Wahlershausen, Kassel
Neuropraxis Muenchen Sued
N/A, Hauptstrasse 2, 82008, Unterhaching
Intermed Institut fuer medizinische Forschung und Arzneimittelsicherheit GmbH
N/A, Hasengartenstrasse 42, 65189, Wiesbaden
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
N/A, Heikendorfer Weg 9-27, Neumuehlen-Dietrichsdorf, Kiel
Klinische Forschung Hannover-Mitte GmbH
N/A, Schillerstrasse 30, Mitte, Hanover
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
N/A, Lange Strasse 25, 26655, Westerstede
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Neurológiai Osztály, Tallian Gyula Utca 20-32, 7400, Kaposvar
Gyongyosi Bugat Pal Korhaz
Neurológiai Szakrendelés, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
S-Medicon Kft.
N/A, Madarasz Viktor Utca 47-49, 1138, Budapest XIII
Neurological Institute Foundation Casimiro Mondino
N/A, Via Casimiro Mondino 2, 27100, Pavia
Irccs San Raffaele Roma S.r.l.
N/A, Via Della Pisana 235, 00163, Rome
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
N/A, Via Saragat Localita Campo Di Pile, 67100, L'Aquila
IRCCS Foundation Istituto Neurologico Carlo Besta
N/A, Via Giovanni Celoria 11, 20133, Milan
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
Canisius Wilhelmina Hospital
N/A, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
ZorgSaam Ziekenhuis
N/A, Wielingenlaan 2, 4535 PA, Terneuzen
Vitamed Galaj I Cichomski Sp. j.
N/A, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Solumed Sp. z o.o. sp.k.
N/A, Ul. Jana Henryka Dabrowskiego 77a, 60-529, Poznan
Euromedis Sp. z o.o.
N/A, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Silmedic Sp. z o.o.
N/A, Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
N/A, ul. Łubinowa 12/7, 52-210, Wrocław
Specjalistyczne Gabinety Sp. z o.o.
N/A, Pl. Lasoty 4, 30-539, Cracow
Pratia S.A.
N/A, Ul. Chrzanowskiego 3 Lok 5, 81-338, Gdynia
Indywidualna Praktyka Lekarska Dr. hab. med. Anna Szczepanska-Szerej
N/A, Ul. Onyksowa 12, 20-582, Lublin
Centrum Leczenia Padaczki I Migreny S.A.
N/A, Fieldorfa Nila 14 Ju 4, 31-209, Cracow
Hospital Universitari Vall D Hebron
N/A, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario De Valladolid
N/A, Avenida Ramon Y Cajal 3, 47003, Valladolid
University Hospital Virgen Del Rocio S.L.
N/A, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Czechia | 2021-08-16 | 2025-07-24 | 2021-09-02 | 2022-06-29 | |
| Denmark | 2022-01-14 | 2025-06-11 | 2022-01-27 | 2022-05-21 | |
| France | 2021-12-09 | 2025-07-04 | 2022-02-17 | 2022-06-23 | |
| Germany | 2022-01-14 | 2025-07-29 | 2022-01-18 | 2022-06-22 | |
| Hungary | 2022-02-16 | 2025-07-23 | 2022-03-01 | 2022-06-28 | |
| Italy | 2021-11-19 | 2025-10-09 | 2021-12-13 | 2022-09-13 | |
| Netherlands | 2022-01-29 | 2025-05-01 | 2022-02-08 | 2022-06-17 | |
| Poland | 2021-09-15 | 2025-07-16 | 2021-09-21 | 2022-06-24 | |
| Spain | 2022-02-24 | 2025-08-04 | 2022-04-24 | 2022-09-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-DE-0001
- Member state
- Germany
- Publication date
- 2024-06-26
- 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 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_3101312002-protocol-redacted | 6 |
| Recruitment arrangements (for publication) | 3101-312-002_DK_Danish Protocol Supplemental_ Public | 1.1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Subject information and informed consent form (for publication) | 3101-312-002 CZ - ICF PregPart IRB Approved_Public | 3.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 CZ - ICF Privacy IRB Approved_Public | 3.1.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 DE - ICF Submission Informed Consent Pregnant Partner_Public | 4.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 DK - Other Information Given to Subjects_public | 2 |
| Subject information and informed consent form (for publication) | 3101-312-002 ES - ICF PregPart IRB Approved_Public | 3.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 FR - ICF PregPart_Public | 4.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 HU - ICF PregPart Country Sample_public | 3.1 |
| Subject information and informed consent form (for publication) | 3101-312-002 HU - ICF PregPart Country Sample- PIS_public | 3.1 |
| Subject information and informed consent form (for publication) | 3101-312-002 HU - ICF Submission Informed Consent Main PIS_public | 3.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 HU - ICF Submission Informed Consent Main_public | 3.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 HU_Pregnant Partner PIS_ICF_Hungarian_Public | 4.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 IT ICF Pregnant Authorization for Data release form_Public | 2.0 |
| Subject information and informed consent form (for publication) | 3101-312-002 PL ICF Pregnant Parter_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 3101-312-002 CZ Main ICF_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1 3101-312-002 DE Main ICF _Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_3101-312-002 ES ICF Main_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_3101-312-002 FR ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_3101-312-002 IT ICF Main_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_3101-312-002 NL ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_3101-312-002 PL ICF Main_Public | 5 |
| Subject information and informed consent form (for publication) | L1_3101-312-002_DK_ICF Main_public | 5 |
| Subject information and informed consent form (for publication) | L1_3101-312-002_DK_ICF Pregnant Partner_public | 4 |
| Subject information and informed consent form (for publication) | L1_3101-312-002_HU_PIS_ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_3101-312-002_DK_Dine rettigheder som forsgsperson i forsg med medicin_public | 1 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-CS-CZ | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-ES-ES | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-HU-HU | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-IT-IT | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-lay-FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-NL-NL | 6 |
| Synopsis of the protocol (for publication) | D1_3101312002-protocol-synopsis-PL-PL | 6 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-07 | Italy | Acceptable 2023-12-18
|
2023-12-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-05 | Acceptable 2023-12-18
|
2024-03-05 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-10 | Italy | Acceptable with conditions 2024-08-19
|
2024-08-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-08 | Acceptable with conditions | 2024-10-22 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-08 | Acceptable with conditions | 2024-10-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-18 | Italy | Acceptable 2025-04-07
|
2025-04-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-24 | Acceptable | 2025-04-30 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-09 | Acceptable | 2025-05-09 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-05-30 | Italy | Acceptable 2025-07-14
|
2025-07-15 |