Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
ATO-TOPIRAMATE
A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)
2 other identifiers
interventional
545
12 countries
81
Brief Summary
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
October 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMay 25, 2025
May 1, 2025
1.6 years
February 20, 2023
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to Week 24 (Double-blind treatment period)
Secondary Outcomes (6)
Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.
Month 4 to Month 6 (Double-blind treatment period)
Change From Baseline in Mean Monthly Migraine Days
Month 4 to Month 6 (Double-blind treatment period)
Change from Baseline in HIT-6 (Headache Impact Test) Total Score
At Week 24
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
At Week 24
Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC)
At Week 24
- +1 more secondary outcomes
Study Arms (2)
Atogepant
EXPERIMENTALParticipants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Topiramate
ACTIVE COMPARATORParticipants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Have used topiramate or atogepant in the past.
- Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (81)
Medizinische Universitaet Innsbruck /ID# 247213
Innsbruck, Tyrol, 6020, Austria
Konventhospital Barmherzige Brueder Linz /ID# 247217
Linz, Upper Austria, 4021, Austria
Medizinische Universitaet Wien /ID# 247119
Vienna, Vienna, 1090, Austria
Universitair Ziekenhuis Brussel /ID# 246959
Jette, Brussels Capital, 1090, Belgium
Jessa Ziekenhuis /ID# 246954
Hasselt, Limburg, 3500, Belgium
UZ Gent /ID# 246957
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Sint-Jan Brugge /ID# 246962
Bruges, 8000, Belgium
CHR de la Citadelle /ID# 246964
Liège, 4000, Belgium
Vancouver Island Health Authority /ID# 247733
Victoria, British Columbia, V8R 1J8, Canada
Maritime Neurology /ID# 247728
Halifax, Nova Scotia, B3R 1V9, Canada
Aggarwal and Associates Limited /ID# 247727
Brampton, Ontario, L6T 0G1, Canada
CCR Ostrava, s.r.o. /ID# 245924
Ostrava, Ostrava-mesto, 702 00, Czechia
A-Shine s.r.o. /ID# 245923
Pilsen, Plzeň Region, 301 00, Czechia
Praglandia /ID# 247511
Prague, Praha 5, 150 00, Czechia
NeuroHK s.r.o. /ID# 247500
Hradec Králové, 500 09, Czechia
Pratia Pardubice a.s. /ID# 249017
Pardubice, 530 02, Czechia
Clintrial s.r.o. /ID# 245926
Prague, 100 00, Czechia
Pratia Prague s.r.o. /ID# 245925
Prague, 130 00, Czechia
Fakultni Thomayerova nemocnice /ID# 249016
Prague, 140 59, Czechia
INEP medical s.r.o. /ID# 245927
Prague, 186 00, Czechia
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562
Bron, Rhone, 69500, France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561
Clermont-Ferrand, 63000, France
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244
Paris, 75010, France
Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236
Böblingen, Baden-Wurttemberg, 71034, Germany
Universitaetsklinikum Tuebingen /ID# 246043
Tübingen, Baden-Wurttemberg, 72076, Germany
Neuropoint GmbH /ID# 246038
Ulm, Baden-Wurttemberg, 89073, Germany
Neuropraxis Muenchen Sued /ID# 246045
Unterhaching, Bavaria, 82008, Germany
Gesundheitszentrum Hoppegarten /ID# 249242
Hoppegarten, Brandenburg, 15366, Germany
Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427
Bad Homburg, Hesse, 61348, Germany
Kopfschmerzzentrum - Frankfurt /ID# 248686
Frankfurt am Main, Hesse, 65929, Germany
Klinische Forschung Hannover-Mitte GmbH /ID# 248565
Hanover, Lower Saxony, 30159, Germany
Studienzentrum Nord-West /ID# 246039
Westerstede, Lower Saxony, 26655, Germany
Klinische Forschung Schwerin GmbH /ID# 248074
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
ZNS Siegen /ID# 251180
Siegen, North Rhine-Westphalia, 57076, Germany
Krankenhaus der Barmherzigen Brüder Trier /ID# 248564
Trier, Rhineland-Palatinate, 54292, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030
Chemnitz, Saxony, 09111, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040
Dresden, Saxony, 01307, Germany
Ambenet Hausarztpraxis /ID# 246028
Leipzig, Saxony, 04107, Germany
Schmerzklinik Kiel /ID# 246037
Kiel, Schleswig-Holstein, 24149, Germany
Neurologisches Facharztzentrum Berlin /ID# 248064
Berlin, 10713, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029
Berlin, 13353, Germany
NeuroZentrum Bielefeld /ID# 250758
Bielefeld, 33647, Germany
Neuro Centrum Odenwald /ID# 248067
Erbach im Odenwald, 64711, Germany
Universitaetsklinikum Essen /ID# 246033
Essen, 45147, Germany
Universitaetsmedizin Greifswald /ID# 248574
Greifswald, 17475, Germany
Klinische Forschung Hamburg GmbH /ID# 248620
Hamburg, 20253, Germany
Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085
Kassel, 34121, Germany
Lewis Neurologie /ID# 250498
Stuttgart, 70178, Germany
MIND Clinic /ID# 247867
Budapest, 1024, Hungary
Clinexpert Kft /ID# 247868
Budapest, 1033, Hungary
Semmelweis Egyetem /ID# 248428
Budapest, 1085, Hungary
S-Medicon Kft /ID# 247682
Budapest, 1138, Hungary
Debreceni Egeszsegugyi Kozpontja /ID# 247549
Debrecen, 4025, Hungary
Meir Medical Center /ID# 247261
Kfar Saba, Central District, 4428164, Israel
Hillel Yaffe Medical Center /ID# 247258
Hadera, H_efa, 38100, Israel
Shaare Zedek Medical Center /ID# 247259
Jerusalem, Jerusalem, 91031, Israel
Soroka University Medical Center /ID# 247260
Beersheba, Southern District, 8410101, Israel
Azienda Ospedaliero Universitaria Careggi /ID# 247575
Florence, Firenze, 50134, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576
Naples, Napoli, 80138, Italy
IRCCS San Raffaele /ID# 247573
Rome, Roma, 00163, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 247578
Modena, 41124, Italy
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579
Pavia, 27100, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580
Roma, 00128, Italy
Solumed Centrum Medyczne /ID# 247317
Poznan, Greater Poland Voivodeship, 60-529, Poland
Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323
Poznan, Greater Poland Voivodeship, 61-731, Poland
Vitamed Galaj i Cichomski Sp.j. /ID# 247314
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Athleticomed Sp. z o.o /ID# 250790
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298
Lublin, Lublin Voivodeship, 20-582, Poland
RCMed Oddzial Sochaczew /ID# 247378
Sochaczew, Masovian Voivodeship, 96-500, Poland
ETG Neuroscience Sp. z o.o. /ID# 247331
Warsaw, Masovian Voivodeship, 02-677, Poland
Silmedic Sp. z o.o. /ID# 247376
Katowice, Silesian Voivodeship, 40-282, Poland
Hospital Garcia de Orta /ID# 247163
Almada, Setúbal District, 2805-267, Portugal
2CA-Braga, Hospital de Braga /ID# 247165
Braga, 4710-243, Portugal
Hospital da Luz Lisboa /ID# 247168
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 247167
Lisbon, 1649-035, Portugal
Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172
Lisbon, 2720-276, Portugal
Unidade Local de Saúde de Matosinhos, EPE /ID# 247169
Matosinhos Municipality, 4464-513, Portugal
The Adam Practice /ID# 248880
Poole, Dorset, BH15 4JQ, United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 247979
Glasgow, Scotland, G12 0XH, United Kingdom
West Walk Surgery /ID# 252855
Bristol, BS37 4AX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
February 28, 2023
Study Start
October 7, 2023
Primary Completion
April 28, 2025
Study Completion
May 1, 2026
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.