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

Phase 3

Active, not recruiting

• Conditions: Migraine
• Interventions: Drug: Atogepant; Drug: Placebo for Topiramate; Drug: Placebo for Atogepant; Drug: Topiramate

• Registration Number: NCT05748483
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-28
• Study Start: 2023-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-04-24
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 545

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Atogepant	Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Atogepant	Placebo for Topiramate	Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Topiramate	Placebo for Atogepant	Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Atogepant	Atogepant	Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Topiramate	Topiramate	Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Improvement in mean monthly migraine days will be assessed.
Change From Baseline in Mean Monthly Migraine Days	Month 4 to Month 6 (Double-blind treatment period)	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Change from Baseline in HIT-6 (Headache Impact Test) Total Score	At Week 24	The HIT-6 is a self-report questionnaire designed to evaluate the impact of headache on quality of life. 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).
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive 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.
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	The PGIC is a single item used to measure the participants impression of overall change in migraine since the first dose of study medication. The measure uses a 7-point rating scale with responses ranging from "very much better" to "very much worse."
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function -Abilities Subset -Short Form 6a Version 2.0 score.	At Week 6	The Patient Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function and Cognitive Function Abilities Subset item banks assess participant perceived cognitive deficits. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. The extent to which cognitive impairments interfere with daily functioning, whether other people observe cognitive impairments, and the impact of cognitive dysfunction on quality of life are also assessed. (Subset of participants when and where available)

Trial Locations

Locations (81)

Praglandia /ID# 247511; 🇨🇿 Prague, Praha 5, Czechia

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040; 🇩🇪 Dresden, Sachsen, Germany

Universitair Ziekenhuis Brussel /ID# 246959; 🇧🇪 Jette, Bruxelles-Capitale, Belgium

Jessa Ziekenhuis /ID# 246954; 🇧🇪 Hasselt, Limburg, Belgium

UZ Gent /ID# 246957; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576; 🇮🇹 Naples, Napoli, Italy

Konventhospital Barmherzige Brueder Linz /ID# 247217; 🇦🇹 Linz, Oberoesterreich, Austria

Medizinische Universitaet Innsbruck /ID# 247213; 🇦🇹 Innsbruck, Tirol, Austria

Medizinische Universitaet Wien /ID# 247119; 🇦🇹 Vienna, Wien, Austria

AZ Sint-Jan Brugge /ID# 246962; 🇧🇪 Brugge, Belgium

CHR de la Citadelle /ID# 246964; 🇧🇪 Liege, Belgium

Vancouver Island Health Authority /ID# 247733; 🇨🇦 Victoria, British Columbia, Canada

Maritime Neurology /ID# 247728; 🇨🇦 Halifax, Nova Scotia, Canada

Aggarwal and Associates Limited /ID# 247727; 🇨🇦 Brampton, Ontario, Canada

CCR Ostrava, s.r.o. /ID# 245924; 🇨🇿 Ostrava, Ostrava-mesto, Czechia

A-Shine s.r.o. /ID# 245923; 🇨🇿 Plzen, Plzensky Kraj, Czechia

NeuroHK s.r.o. /ID# 247500; 🇨🇿 Hradec Kralove, Czechia

Pratia Pardubice a.s. /ID# 249017; 🇨🇿 Pardubice, Czechia

Clintrial s.r.o. /ID# 245926; 🇨🇿 Prague 10, Czechia

Pratia Prague s.r.o. /ID# 245925; 🇨🇿 Prague, Czechia

Fakultni Thomayerova nemocnice /ID# 249016; 🇨🇿 Praha, Czechia

INEP medical s.r.o. /ID# 245927; 🇨🇿 Praha, Czechia

Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562; 🇫🇷 Bron, Rhone, France

CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561; 🇫🇷 Clermont Ferrand, France

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244; 🇫🇷 Paris, France

Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236; 🇩🇪 Boeblingen, Baden-Wuerttemberg, Germany

Universitaetsklinikum Tuebingen /ID# 246043; 🇩🇪 Tubingen, Baden-Wuerttemberg, Germany

Neuropoint GmbH /ID# 246038; 🇩🇪 Ulm, Baden-Wuerttemberg, Germany

Neuropraxis Muenchen Sued /ID# 246045; 🇩🇪 Unterhaching, Bayern, Germany

Gesundheitszentrum Hoppegarten /ID# 249242; 🇩🇪 Hoppegarten, Brandenburg, Germany

Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427; 🇩🇪 Bad Homburg, Hessen, Germany

Klinische Forschung Schwerin GmbH /ID# 248074; 🇩🇪 Schwerin, Mecklenburg-Vorpommern, Germany

Klinische Forschung Hannover-Mitte GmbH /ID# 248565; 🇩🇪 Hannover, Niedersachsen, Germany

Studienzentrum Nord-West /ID# 246039; 🇩🇪 Westerstede, Niedersachsen, Germany

ZNS Siegen /ID# 251180; 🇩🇪 Siegen, Nordrhein-Westfalen, Germany

Krankenhaus der Barmherzigen Brüder Trier /ID# 248564; 🇩🇪 Trier, Rheinland-Pfalz, Germany

Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030; 🇩🇪 Chemnitz, Sachsen, Germany

AmBeNet GmbH /ID# 246028; 🇩🇪 Leipzig, Sachsen, Germany

Schmerzklinik Kiel /ID# 246037; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Neurologisches Facharztzentrum Berlin /ID# 248064; 🇩🇪 Berlin, Germany

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029; 🇩🇪 Berlin, Germany

NeuroZentrum Bielefeld /ID# 250758; 🇩🇪 Bielefeld, Germany

Neuro Centrum Odenwald /ID# 248067; 🇩🇪 Erbach, Germany

Universitaetsklinikum Essen /ID# 246033; 🇩🇪 Essen, Germany

Kopfschmerzzentrum Frankfurt /ID# 248686; 🇩🇪 Frankfurt am Main, Germany

Universitaetsmedizin Greifswald /ID# 248574; 🇩🇪 Greifswald, Germany

Klinische Forschung Hamburg GmbH /ID# 248620; 🇩🇪 Hamburg, Germany

Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085; 🇩🇪 Kassel, Germany

Lewis Neurologie /ID# 250498; 🇩🇪 Stuttgart, Germany

Mind Klinika Kft. /ID# 247867; 🇭🇺 Budapest, Hungary

Clinexpert Kft /ID# 247868; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem /ID# 248428; 🇭🇺 Budapest, Hungary

S-Medicon Kft /ID# 247682; 🇭🇺 Budapest, Hungary

Debreceni Egeszsegugyi Kozpontja /ID# 247549; 🇭🇺 Debrecen, Hungary

Hillel Yaffe Medical Center /ID# 247258; 🇮🇱 Hadera, H_efa, Israel

Soroka University Medical Center /ID# 247260; 🇮🇱 Be'er Sheva, HaDarom, Israel

Meir Medical Center /ID# 247261; 🇮🇱 Kfar Saba, HaMerkaz, Israel

Shaare Zedek Medical Center /ID# 247259; 🇮🇱 Jerusalem, Yerushalayim, Israel

Azienda Ospedaliero Universitaria Careggi /ID# 247575; 🇮🇹 Florence, Firenze, Italy

IRCCS San Raffaele /ID# 247573; 🇮🇹 Rome, Roma, Italy

Azienda Ospedaliero-Universitaria di Modena /ID# 247578; 🇮🇹 Modena, Italy

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579; 🇮🇹 Pavia, Italy

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580; 🇮🇹 Roma, Italy

Vitamed Galaj i Cichomski Sp.j. /ID# 247314; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Athleticomed Sp. z o.o /ID# 250790; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298; 🇵🇱 Lublin, Lubelskie, Poland

Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315; 🇵🇱 Oświęcim, Malopolskie, Poland

RCMed Oddzial Sochaczew /ID# 247378; 🇵🇱 Sochaczew, Mazowieckie, Poland

ETG Neuroscience Sp. z o.o. /ID# 247331; 🇵🇱 Warszawa, Mazowieckie, Poland

Silmedic Sp. z o.o. /ID# 247376; 🇵🇱 Katowice, Slaskie, Poland

Solumed Centrum Medyczne /ID# 247317; 🇵🇱 Poznan, Wielkopolskie, Poland

Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323; 🇵🇱 Poznan, Wielkopolskie, Poland

Hospital Garcia de Orta /ID# 247163; 🇵🇹 Almada, Setubal, Portugal

2CA-Braga, Hospital de Braga /ID# 247165; 🇵🇹 Braga, Portugal

Hospital da Luz Lisboa /ID# 247168; 🇵🇹 Lisboa, Portugal

Unidade Local de Saude de Santa Maria, EPE /ID# 247167; 🇵🇹 Lisboa, Portugal

Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172; 🇵🇹 Lisboa, Portugal

Unidade Local de Saúde de Matosinhos, EPE /ID# 247169; 🇵🇹 Matosinhos, Portugal

The Adam Practice /ID# 248880; 🇬🇧 Poole, Dorset, United Kingdom

NHS Greater Glasgow and Clyde /ID# 247979; 🇬🇧 Glasgow, Scotland, United Kingdom

West Walk Surgery /ID# 252855; 🇬🇧 Bristol, United Kingdom