Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine (TEMPLE)

April 22, 2024 updated by: AbbVie

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Recruiting
        • Konventhospital Barmherzige Brueder Linz /ID# 247217
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck /ID# 247213
    • Wien
      • Vienna, Wien, Austria, 1090
        • Recruiting
        • Medizinische Universitaet Wien /ID# 247119
        • Contact:
          • Site Coordinator
          • Phone Number: +431 40400 31450
  • Belgium
      • Brugge, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge /ID# 246962
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis /ID# 246954
    • Bruxelles-Capitale
      • Jette, Bruxelles-Capitale, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel /ID# 246959
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent /ID# 246957
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Recruiting
        • Vancouver Island Health Authority /ID# 247733
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3R 1V9
        • Recruiting
        • Maritime Neurology /ID# 247728
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Recruiting
        • Aggarwal and Associates Limited /ID# 247727
  • Czechia
      • Hradec Kralove, Czechia, 500 09
        • Recruiting
        • NeuroHK s.r.o. /ID# 247500
      • Ostrava, Czechia, 702 00
        • Recruiting
        • CCR Ostrava, s.r.o. /ID# 245924
      • Pardubice, Czechia, 530 02
        • Recruiting
        • Pratia Pardubice a.s. /ID# 249017
      • Plzen, Czechia, 301 00
        • Recruiting
        • A-Shine s.r.o. /ID# 245923
      • Prague, Czechia, 130 00
        • Completed
        • Pratia Prague s.r.o. /ID# 245925
      • Prague 10, Czechia, 100 00
        • Recruiting
        • Clintrial s.r.o. /ID# 245926
      • Praha, Czechia, 186 00
        • Recruiting
        • INEP medical s.r.o. /ID# 245927
      • Praha, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova nemocnice /ID# 249016
      • Praha 5, Czechia, 150 00
        • Recruiting
        • Praglandia s.r.o. /ID# 247511
        • Contact:
          • Site Coordinator
          • Phone Number: +420 608 052 214
  • France
      • Bron, France, 69677
        • Recruiting
        • Hôpital Pierre Wertheimer /ID# 247562
        • Contact:
          • Site Coordinator
          • Phone Number: 33 4 72 35 58 38
      • Clermont Ferrand, France, 63000
        • Recruiting
        • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561
      • Paris, France, 75010
        • Recruiting
        • AP-HP - Hopital Lariboisière /ID# 249244
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029
      • Berlin, Germany, 10713
        • Recruiting
        • Neurologisches Facharztzentrum Berlin /ID# 248064
      • Bielefeld, Germany, 33647
        • Recruiting
        • NeuroZentrum Bielefeld /ID# 250758
        • Contact:
          • Site Coordinator
          • Phone Number: +49521443069
      • Chemnitz, Germany, 09111
        • Recruiting
        • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 246040
        • Contact:
          • Site Coordinator
          • Phone Number: 0049 351 458-2063
      • Erbach, Germany, 64711
        • Recruiting
        • Neuro Centrum Odenwald /ID# 248067
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen /ID# 246033
      • Frankfurt am Main, Germany, 65929
        • Recruiting
        • Kopfschmerzzentrum Frankfurt /ID# 248686
      • Greifswald, Germany, 17475
        • Recruiting
        • Universitaetsmedizin Greifswald /ID# 248574
      • Hamburg, Germany, 20253
        • Recruiting
        • Klinische Forschung Hamburg GmbH /ID# 248620
      • Hoppegarten, Germany, 15366
        • Recruiting
        • Gesundheitszentrum Hoppegarten /ID# 249242
        • Contact:
          • Site Coordinator
          • Phone Number: 0049 3342 422930
      • Kassel, Germany, 34121
        • Recruiting
        • Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085
      • Kiel, Germany, 24149
        • Recruiting
        • Schmerzklinik Kiel /ID# 246037
      • Leipzig, Germany, 04107
        • Recruiting
        • AmBeNet GmbH /ID# 246028
        • Contact:
          • Site Coordinator
          • Phone Number: 0049 341 96276329
      • Schwerin, Germany, 19055
        • Recruiting
        • Klinische Forschung Schwerin GmbH /ID# 248074
      • Siegen, Germany, 57076
        • Recruiting
        • ZNS GmbH /ID# 251180
      • Stuttgart, Germany, 70178
        • Recruiting
        • Lewis Neurologie /ID# 250498
        • Contact:
          • Site Coordinator
          • Phone Number: +49 711 . 61 36 61
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier /ID# 248564
      • Ulm, Germany, 89073
        • Recruiting
        • Neuropoint GmbH /ID# 246038
      • Unterhaching, Germany, 82008
        • Recruiting
        • Neuropraxis Muenchen Sued /ID# 246045
        • Contact:
          • Site Coordinator
          • Phone Number: 0049 89 452243619
      • Westerstede, Germany, 26655
        • Recruiting
        • Studienzentrum Nord-West /ID# 246039
    • Baden-Wuerttemberg
      • Boeblingen, Baden-Wuerttemberg, Germany, 71034
        • Recruiting
        • Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236
      • Tubingen, Baden-Wuerttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen /ID# 246043
        • Contact:
          • Site Coordinator
          • Phone Number: 0049 7071 29 85711
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
        • Recruiting
        • Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Recruiting
        • Klinische Forschung Hannover-Mitte GmbH /ID# 248565
  • Hungary
      • Budapest, Hungary, 1024
        • Recruiting
        • Mind Klinika Kft. /ID# 247867
      • Budapest, Hungary, 1033
        • Recruiting
        • Clinexpert Kft /ID# 247868
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem /ID# 248428
      • Budapest, Hungary, 1138
        • Recruiting
        • S-Medicon Kft /ID# 247682
      • Debrecen, Hungary, 4025
        • Recruiting
        • Debreceni Egeszsegugyi Kozpontja /ID# 247549
  • Israel
    • H_efa
      • Hadera, H_efa, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center /ID# 247258
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8410101
        • Recruiting
        • Soroka University Medical Center /ID# 247260
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 4428164
        • Recruiting
        • Meir Medical Center /ID# 247261
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91031
        • Recruiting
        • Shaare Zedek Medical Center /ID# 247259
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi /ID# 247575
      • Napoli, Italy, 80138
        • Recruiting
        • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 247576
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico /ID# 247579
    • Roma
      • Rome, Roma, Italy, 00163
        • Recruiting
        • IRCCS San Raffaele Pisana /ID# 247573
      • Rome, Roma, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 247580
  • Poland
      • Bydgoszcz, Poland, 85-752
        • Recruiting
        • Athleticomed Sp. z o.o /ID# 250790
      • Katowice, Poland, 40-282
        • Recruiting
        • Silmedic Sp. z o.o. /ID# 247376
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
        • Recruiting
        • Vitamed Galaj i Cichomski Sp.j. /ID# 247314
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Recruiting
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298
    • Malopolskie
      • Oświęcim, Malopolskie, Poland, 32-600
        • Recruiting
        • Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315
    • Mazowieckie
      • Sochaczew, Mazowieckie, Poland, 96-500
        • Recruiting
        • RCMed Oddzial Sochaczew /ID# 247378
      • Warszawa, Mazowieckie, Poland, 02-677
        • Recruiting
        • ETG Neuroscience Sp. z o.o. /ID# 247331
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-529
        • Recruiting
        • Solumed Centrum Medyczne /ID# 247317
      • Poznan, Wielkopolskie, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Hospital Garcia de Orta, EPE /ID# 247163
      • Braga, Portugal, 4710-243
        • Recruiting
        • 2CA-Braga, Hospital de Braga /ID# 247165
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 247167
      • Lisboa, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz Lisboa /ID# 247168
      • Lisboa, Portugal, 2720-276
        • Recruiting
        • Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172
      • Matosinhos, Portugal, 4464-513
        • Recruiting
        • Unidade Local de Saúde de Matosinhos, EPE /ID# 247169
        • Contact:
          • Site Coordinator
          • Phone Number: +351 22 939 1000
  • United Kingdom
      • Bristol, United Kingdom, BS37 4AX
        • Recruiting
        • West Walk Surgery /ID# 252855
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 4JQ
        • Recruiting
        • The Adam Practice /ID# 248880
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • Recruiting
        • NHS Greater Glasgow and Clyde /ID# 247979

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  • Have used topiramate or atogepant in the past.
  • Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atogepant
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Drug: Atogepant
Oral Tablet
Other Names:
  • QULIPTA
Drug: Placebo for Topiramate
Oral Capsule
Active Comparator: Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Drug: Atogepant
Oral Tablet
Other Names:
  • QULIPTA
Drug: Placebo for Atogepant
Oral Tablet
Drug: Topiramate
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Time Frame: Up to Week 24 (Double-blind treatment period)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.
Time Frame: Month 4 to Month 6 (Double-blind treatment period)
Improvement in mean monthly migraine days will be assessed.
Month 4 to Month 6 (Double-blind treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2023

Primary Completion (Estimated)

June 14, 2026

Study Completion (Estimated)

June 29, 2026

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M22-061
  • 2022-501172-25-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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