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MigrainePhase 3ATO-TOPIRAMATENCT05748483

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

A Phase 3 study testing Atogepant and Topiramate in people with Migraine, run by AbbVie at 81 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Migraine
What is being tested?
Atogepant and Topiramate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
545 participants
Where
81 sitesin 12 countries
Study dates
7 Oct 2023to 2 Jun 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

81 sites in 12 countries.

81 sites in 12 countries

Germany25 sites

  • Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427

    Bad Homburg, Hesse, 61348

  • Neurologisches Facharztzentrum Berlin /ID# 248064

    Berlin, 10713

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029

    Berlin, 13353

  • NeuroZentrum Bielefeld /ID# 250758

    Bielefeld, 33647

  • Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236

    Böblingen, Baden-Wurttemberg, 71034

  • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030

    Chemnitz, Saxony, 09111

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040

    Dresden, Saxony, 01307

  • Neuro Centrum Odenwald /ID# 248067

    Erbach im Odenwald, 64711

  • Universitaetsklinikum Essen /ID# 246033

    Essen, 45147

  • Kopfschmerzzentrum - Frankfurt /ID# 248686

    Frankfurt am Main, Hesse, 65929

  • Universitaetsmedizin Greifswald /ID# 248574

    Greifswald, 17475

  • Klinische Forschung Hamburg GmbH /ID# 248620

    Hamburg, 20253

  • Klinische Forschung Hannover-Mitte GmbH /ID# 248565

    Hanover, Lower Saxony, 30159

  • Gesundheitszentrum Hoppegarten /ID# 249242

    Hoppegarten, Brandenburg, 15366

  • Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085

    Kassel, 34121

  • Schmerzklinik Kiel /ID# 246037

    Kiel, Schleswig-Holstein, 24149

  • Ambenet Hausarztpraxis /ID# 246028

    Leipzig, Saxony, 04107

  • Klinische Forschung Schwerin GmbH /ID# 248074

    Schwerin, Mecklenburg-Vorpommern, 19055

  • ZNS Siegen /ID# 251180

    Siegen, North Rhine-Westphalia, 57076

  • Lewis Neurologie /ID# 250498

    Stuttgart, 70178

  • Krankenhaus der Barmherzigen Brüder Trier /ID# 248564

    Trier, Rhineland-Palatinate, 54292

  • Universitaetsklinikum Tuebingen /ID# 246043

    Tübingen, Baden-Wurttemberg, 72076

  • Neuropoint GmbH /ID# 246038

    Ulm, Baden-Wurttemberg, 89073

  • Neuropraxis Muenchen Sued /ID# 246045

    Unterhaching, Bavaria, 82008

  • Studienzentrum Nord-West /ID# 246039

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Czechia9 sites

  • NeuroHK s.r.o. /ID# 247500

    Hradec Králové, 500 09

  • CCR Ostrava, s.r.o. /ID# 245924

    Ostrava, Ostrava-mesto, 702 00

  • Pratia Pardubice a.s. /ID# 249017

    Pardubice, 530 02

  • A-Shine s.r.o. /ID# 245923

    Pilsen, Plzeň Region, 301 00

  • Praglandia /ID# 247511

    Prague, Praha 5, 150 00

  • Clintrial s.r.o. /ID# 245926

    Prague, 100 00

  • Pratia Prague s.r.o. /ID# 245925

    Prague, 130 00

  • Fakultni Thomayerova nemocnice /ID# 249016

    Prague, 140 59

  • INEP medical s.r.o. /ID# 245927

    Prague, 186 00

Other trials in Czechia

Poland9 sites

  • Vitamed Galaj i Cichomski Sp.j. /ID# 247314

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Athleticomed Sp. z o.o /ID# 250790

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

  • Silmedic Sp. z o.o. /ID# 247376

    Katowice, Silesian Voivodeship, 40-282

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298

    Lublin, Lublin Voivodeship, 20-582

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Solumed Centrum Medyczne /ID# 247317

    Poznan, Greater Poland Voivodeship, 60-529

  • Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323

    Poznan, Greater Poland Voivodeship, 61-731

  • RCMed Oddzial Sochaczew /ID# 247378

    Sochaczew, Masovian Voivodeship, 96-500

  • ETG Neuroscience Sp. z o.o. /ID# 247331

    Warsaw, Masovian Voivodeship, 02-677

Other trials in Poland

Italy6 sites

  • Azienda Ospedaliero Universitaria Careggi /ID# 247575

    Florence, Firenze, 50134

  • Azienda Ospedaliero-Universitaria di Modena /ID# 247578

    Modena, 41124

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576

    Naples, Napoli, 80138

  • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579

    Pavia, 27100

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580

    Roma, 00128

  • IRCCS San Raffaele /ID# 247573

    Rome, Roma, 00163

Other trials in Italy

Portugal6 sites

  • Hospital Garcia de Orta /ID# 247163

    Almada, Setúbal District, 2805-267

  • 2CA-Braga, Hospital de Braga /ID# 247165

    Braga, 4710-243

  • Hospital da Luz Lisboa /ID# 247168

    Lisbon, 1500-650

  • Unidade Local de Saude de Santa Maria, EPE /ID# 247167

    Lisbon, 1649-035

  • Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172

    Lisbon, 2720-276

  • Unidade Local de Saúde de Matosinhos, EPE /ID# 247169

    Matosinhos Municipality, 4464-513

Other trials in Portugal

Belgium5 sites

  • AZ Sint-Jan Brugge /ID# 246962

    Bruges, 8000

  • UZ Gent /ID# 246957

    Ghent, Oost-Vlaanderen, 9000

  • Jessa Ziekenhuis /ID# 246954

    Hasselt, Limburg, 3500

  • Universitair Ziekenhuis Brussel /ID# 246959

    Jette, Brussels Capital, 1090

  • CHR de la Citadelle /ID# 246964

    Liège, 4000

Other trials in Belgium

Hungary5 sites

  • MIND Clinic /ID# 247867

    Budapest, 1024

  • Clinexpert Kft /ID# 247868

    Budapest, 1033

  • Semmelweis Egyetem /ID# 248428

    Budapest, 1085

  • S-Medicon Kft /ID# 247682

    Budapest, 1138

  • Debreceni Egeszsegugyi Kozpontja /ID# 247549

    Debrecen, 4025

Other trials in Hungary

Israel4 sites

  • Soroka University Medical Center /ID# 247260

    Beersheba, Southern District, 8410101

  • Hillel Yaffe Medical Center /ID# 247258

    Hadera, H_efa, 38100

  • Shaare Zedek Medical Center /ID# 247259

    Jerusalem, Jerusalem, 91031

  • Meir Medical Center /ID# 247261

    Kfar Saba, Central District, 4428164

Other trials in Israel

Austria3 sites

  • Medizinische Universitaet Innsbruck /ID# 247213

    Innsbruck, Tyrol, 6020

  • Konventhospital Barmherzige Brueder Linz /ID# 247217

    Linz, Upper Austria, 4021

  • Medizinische Universitaet Wien /ID# 247119

    Vienna, State of Vienna, 1090

Other trials in Austria

Canada3 sites

  • Aggarwal and Associates Limited /ID# 247727

    Brampton, Ontario, L6T 0G1

  • Maritime Neurology /ID# 247728

    Halifax, Nova Scotia, B3R 1V9

  • Vancouver Island Health Authority /ID# 247733

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

France3 sites

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562

    Bron, Rhone, 69500

  • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561

    Clermont-Ferrand, 63000

  • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244

    Paris, 75010

Other trials in France

United Kingdom3 sites

  • West Walk Surgery /ID# 252855

    Bristol, BS37 4AX

  • Duplicate_NHS Greater Glasgow and Clyde /ID# 247979

    Glasgow, Scotland, G12 0XH

  • The Adam Practice /ID# 248880

    Poole, Dorset, BH15 4JQ

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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.

Conditions
Migraine
Being tested
Atogepant, Placebo for Atogepant, Topiramate, Placebo for Topiramate
Keywords
Migraine, Episodic migraine, Chronic migraine, Atogepant, Topiramine, QULIPTA, Migraine prophylaxis
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called QULIPTA

    Oral Tablet

  • Placebo for AtogepantDrug

    Oral Tablet

  • TopiramateDrug

    Oral Capsule

  • Placebo for TopiramateDrug

    Oral Capsule

Study groups in NCT05748483
Study groupRoleWhat they receive
AtogepantExperimentalParticipants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Receives: Drug: Atogepant; Drug: Placebo for Topiramate
TopiramateActive comparatorParticipants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant; Drug: Topiramate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: Week 24

Secondary outcomes (6)

  1. Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During 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.

    Measured: Months 4 to 6 (DB Period)

  2. Change From Baseline in Mean Monthly Migraine Days During 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.

    Measured: Baseline to Month 4 to Month 6 (DB Period)

  3. Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at 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.

    Measured: Baseline to Week 24

  4. 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

    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.

    Measured: Baseline to Week 24

  5. Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC)

    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.

    Measured: Week 24

  6. Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score

    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.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start7 Oct 2023
  3. Primary completion28 Apr 2025
  4. Study completion2 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748483
Sponsor's protocol ID
M22-061
Other IDs
2022-501172-25-00
Acronym
ATO-TOPIRAMATE
Status last verified
Jun 2026
First submitted
20 Feb 2023
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Reuter U, Dycke AV, Versijpt J, Holle-Lee D, Farkas MK, Tepper SJ, Forero G, Luo L, Guo H, Cohen E, Dabruzzo B, Gandhi P, Nagy K. Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial. Lancet Neurol. 2026 Sep;25(9):806-817. doi: 10.1016/S1474-4422(26)00214-0. Epub 2026 Jul 23.

    PubMed 42492556

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