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

June 26, 2026 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

545

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 Locations

  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Medizinische Universitaet Wien /ID# 247119
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universitaet Innsbruck /ID# 247213
    • Upper Austria
      • Linz, Upper Austria, Austria, 4021
        • Konventhospital Barmherzige Brueder Linz /ID# 247217
  • Belgium
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge /ID# 246962
      • Liège, Belgium, 4000
        • CHR de la Citadelle /ID# 246964
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 246959
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis /ID# 246954
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 246957
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Vancouver Island Health Authority /ID# 247733
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3R 1V9
        • Maritime Neurology /ID# 247728
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited /ID# 247727
  • Czechia
      • Hradec Králové, Czechia, 500 09
        • NeuroHK s.r.o. /ID# 247500
      • Pardubice, Czechia, 530 02
        • Pratia Pardubice a.s. /ID# 249017
      • Prague, Czechia, 130 00
        • Pratia Prague s.r.o. /ID# 245925
      • Prague, Czechia, 100 00
        • Clintrial s.r.o. /ID# 245926
      • Prague, Czechia, 140 59
        • Fakultni Thomayerova nemocnice /ID# 249016
      • Prague, Czechia, 186 00
        • INEP medical s.r.o. /ID# 245927
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 702 00
        • CCR Ostrava, s.r.o. /ID# 245924
    • Plzeň Region
      • Pilsen, Plzeň Region, Czechia, 301 00
        • A-Shine s.r.o. /ID# 245923
    • Praha 5
      • Prague, Praha 5, Czechia, 150 00
        • Praglandia /ID# 247511
  • France
      • Clermont-Ferrand, France, 63000
        • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561
      • Paris, France, 75010
        • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244
    • Rhone
      • Bron, Rhone, France, 69500
        • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562
  • Germany
      • Berlin, Germany, 10713
        • Neurologisches Facharztzentrum Berlin /ID# 248064
      • Berlin, Germany, 13353
        • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029
      • Bielefeld, Germany, 33647
        • NeuroZentrum Bielefeld /ID# 250758
      • Erbach im Odenwald, Germany, 64711
        • Neuro Centrum Odenwald /ID# 248067
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen /ID# 246033
      • Greifswald, Germany, 17475
        • Universitaetsmedizin Greifswald /ID# 248574
      • Hamburg, Germany, 20253
        • Klinische Forschung Hamburg GmbH /ID# 248620
      • Kassel, Germany, 34121
        • Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085
      • Stuttgart, Germany, 70178
        • Lewis Neurologie /ID# 250498
    • Baden-Wurttemberg
      • Böblingen, Baden-Wurttemberg, Germany, 71034
        • Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen /ID# 246043
      • Ulm, Baden-Wurttemberg, Germany, 89073
        • Neuropoint GmbH /ID# 246038
    • Bavaria
      • Unterhaching, Bavaria, Germany, 82008
        • Neuropraxis Muenchen Sued /ID# 246045
    • Brandenburg
      • Hoppegarten, Brandenburg, Germany, 15366
        • Gesundheitszentrum Hoppegarten /ID# 249242
    • Hesse
      • Bad Homburg, Hesse, Germany, 61348
        • Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427
      • Frankfurt am Main, Hesse, Germany, 65929
        • Kopfschmerzzentrum - Frankfurt /ID# 248686
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH /ID# 248565
      • Westerstede, Lower Saxony, Germany, 26655
        • Studienzentrum Nord-West /ID# 246039
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • Klinische Forschung Schwerin GmbH /ID# 248074
    • North Rhine-Westphalia
      • Siegen, North Rhine-Westphalia, Germany, 57076
        • ZNS Siegen /ID# 251180
    • Rhineland-Palatinate
      • Trier, Rhineland-Palatinate, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier /ID# 248564
    • Saxony
      • Chemnitz, Saxony, Germany, 09111
        • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040
      • Leipzig, Saxony, Germany, 04107
        • Ambenet Hausarztpraxis /ID# 246028
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24149
        • Schmerzklinik Kiel /ID# 246037
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 247868
      • Budapest, Hungary, 1138
        • S-Medicon Kft /ID# 247682
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 248428
      • Budapest, Hungary, 1024
        • MIND Clinic /ID# 247867
      • Debrecen, Hungary, 4025
        • Debreceni Egeszsegugyi Kozpontja /ID# 247549
  • Israel
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Meir Medical Center /ID# 247261
    • H_efa
      • Hadera, H_efa, Israel, 38100
        • Hillel Yaffe Medical Center /ID# 247258
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 247259
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Soroka University Medical Center /ID# 247260
  • Italy
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena /ID# 247578
      • Pavia, Italy, 27100
        • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579
      • Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi /ID# 247575
    • Napoli
      • Naples, Napoli, Italy, 80138
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576
    • Roma
      • Rome, Roma, Italy, 00163
        • IRCCS San Raffaele /ID# 247573
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • Solumed Centrum Medyczne /ID# 247317
      • Poznan, Greater Poland Voivodeship, Poland, 61-731
        • Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Vitamed Galaj i Cichomski Sp.j. /ID# 247314
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
        • Athleticomed Sp. z o.o /ID# 250790
    • Lesser Poland Voivodeship
      • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
        • Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298
    • Masovian Voivodeship
      • Sochaczew, Masovian Voivodeship, Poland, 96-500
        • RCMed Oddzial Sochaczew /ID# 247378
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Neuroscience Sp. z o.o. /ID# 247331
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-282
        • Silmedic Sp. z o.o. /ID# 247376
  • Portugal
      • Braga, Portugal, 4710-243
        • 2CA-Braga, Hospital de Braga /ID# 247165
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz Lisboa /ID# 247168
      • Lisbon, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria, EPE /ID# 247167
      • Lisbon, Portugal, 2720-276
        • Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172
      • Matosinhos Municipality, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos, EPE /ID# 247169
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Hospital Garcia de Orta /ID# 247163
  • United Kingdom
      • Bristol, United Kingdom, BS37 4AX
        • West Walk Surgery /ID# 252855
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 4JQ
        • The Adam Practice /ID# 248880
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • Duplicate_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 Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Week 24
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During Months 4 to 6 (DB Period)
Time Frame: Months 4 to 6 (DB Period)
The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 3-month average of monthly migraine days over Months 4 to 6.
Months 4 to 6 (DB Period)
Change From Baseline in Mean Monthly Migraine Days During Months 4 to 6 (DB Period)
Time Frame: Baseline to Month 4 to Month 6 (DB Period)
The mean monthly migraine days across Months 4 to 6 is calculated by taking the 3-month average of monthly migraine days over Months 4 to 6. The monthly migraine days is defined as the total number of recorded migraine days in the eDiary divided by the total number of days with eDiary records during each monthly period and multiplied by 28.
Baseline to Month 4 to Month 6 (DB Period)
Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at Week 24
Time Frame: Baseline to Week 24
The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). Negative changes from Baseline in the HIT-6 score indicate improvement.
Baseline to Week 24
Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Week 24
Time Frame: Baseline to Week 24
MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.
Baseline to Week 24
Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC)
Time Frame: Week 24
The Patient Global Impression of Change (PGIC) is a 7-point response scale. The participant response to the question, "Since you started the study treatment, how would you rate the change in your overall condition?" was assessed. Scores ranged from 1-7 on a scale of 1 (very much improved) to 7 (very much worse). Higher values represent a worse outcome.
Week 24
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score
Time Frame: Baseline to Week 6
The Patient Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function and Cognitive Function Abilities Subset item banks assess patient perceived cognitive deficits (i.e., mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes) over the past 7 days. A 5-level response scale for all 6 items ranges from 1 (Not at all) to 5 (Very much). The raw score of PROMIS-CF is the sum of all 6 items, ranging from 6 to 30. The raw score is standardized into a T-score with a mean of 50 and standard deviation of 10. Higher scores indicate a better cognitive function.
Baseline to Week 6

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 (Actual)

April 28, 2025

Study Completion (Actual)

June 2, 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)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

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 clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

To learn more about 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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