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

Migraine Clinical Trial

— TEMPLE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748483
• Other study ID #: M22-061
• Secondary ID: 2022-501172-25-0
• Status: Recruiting
• Phase: Phase 3
• Start date: October 7, 2023
• Est. completion date: June 28, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: June 28, 2026
• Est. primary completion date: June 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet
• Placebo for Atogepant
Oral Tablet
• Topiramate
Oral Capsule
• Placebo for Topiramate
Oral Capsule

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Innsbruck /ID# 247213	Innsbruck	Tirol
Austria	Konventhospital Barmherzige Brueder Linz /ID# 247217	Linz
Austria	Medizinische Universitaet Wien /ID# 247119	Vienna	Wien
Belgium	AZ Sint-Jan Brugge /ID# 246962	Brugge
Belgium	UZ Gent /ID# 246957	Gent	Oost-Vlaanderen
Belgium	Jessa Ziekenhuis /ID# 246954	Hasselt
Belgium	Universitair Ziekenhuis Brussel /ID# 246959	Jette	Bruxelles-Capitale
Belgium	CHR de la Citadelle /ID# 246964	Liege
Canada	Aggarwal and Associates Limited /ID# 247727	Brampton	Ontario
Canada	Maritime Neurology /ID# 247728	Halifax	Nova Scotia
Canada	Vancouver Island Health Authority /ID# 247733	Victoria	British Columbia
Czechia	NeuroHK s.r.o. /ID# 247500	Hradec Kralove
Czechia	CCR Ostrava, s.r.o. /ID# 245924	Ostrava
Czechia	Pratia Pardubice a.s. /ID# 249017	Pardubice
Czechia	A-Shine s.r.o. /ID# 245923	Plzen
Czechia	Pratia Prague s.r.o. /ID# 245925	Prague
Czechia	Clintrial s.r.o. /ID# 245926	Prague 10
Czechia	Fakultni Thomayerova nemocnice /ID# 249016	Praha
Czechia	INEP medical s.r.o. /ID# 245927	Praha
Czechia	Praglandia s.r.o. /ID# 247511	Praha 5
France	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
Germany	Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427	Bad Homburg	Hessen
Germany	Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029	Berlin
Germany	Neurologisches Facharztzentrum Berlin /ID# 248064	Berlin
Germany	NeuroZentrum Bielefeld /ID# 250758	Bielefeld
Germany	Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236	Boeblingen	Baden-Wuerttemberg
Germany	Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030	Chemnitz
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 246040	Dresden
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	Klinische Forschung Hannover-Mitte GmbH /ID# 248565	Hannover	Niedersachsen
Germany	Gesundheitszentrum Hoppegarten /ID# 249242	Hoppegarten
Germany	Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085	Kassel
Germany	Schmerzklinik Kiel /ID# 246037	Kiel
Germany	AmBeNet GmbH /ID# 246028	Leipzig
Germany	Klinische Forschung Schwerin GmbH /ID# 248074	Schwerin
Germany	ZNS GmbH /ID# 251180	Siegen
Germany	Lewis Neurologie /ID# 250498	Stuttgart
Germany	Krankenhaus der Barmherzigen Brüder Trier /ID# 248564	Trier
Germany	Universitaetsklinikum Tuebingen /ID# 246043	Tubingen	Baden-Wuerttemberg
Germany	Neuropoint GmbH /ID# 246038	Ulm
Germany	Neuropraxis Muenchen Sued /ID# 246045	Unterhaching
Germany	Studienzentrum Nord-West /ID# 246039	Westerstede
Hungary	Clinexpert Kft /ID# 247868	Budapest
Hungary	Mind Klinika Kft. /ID# 247867	Budapest
Hungary	S-Medicon Kft /ID# 247682	Budapest
Hungary	Semmelweis Egyetem /ID# 248428	Budapest
Hungary	Debreceni Egeszsegugyi Kozpontja /ID# 247549	Debrecen
Israel	Soroka University Medical Center /ID# 247260	Be'er Sheva	HaDarom
Israel	Hillel Yaffe Medical Center /ID# 247258	Hadera	H_efa
Israel	Shaare Zedek Medical Center /ID# 247259	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 247261	Kfar Saba	HaMerkaz
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 247575	Florence
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 247578	Modena
Italy	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 247576	Napoli
Italy	Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico /ID# 247579	Pavia
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 247580	Rome	Roma
Italy	IRCCS San Raffaele Pisana /ID# 247573	Rome	Roma
Poland	Athleticomed Sp. z o.o /ID# 250790	Bydgoszcz	Kujawsko-pomorskie
Poland	Vitamed Galaj i Cichomski Sp.j. /ID# 247314	Bydgoszcz	Kujawsko-pomorskie
Poland	Silmedic Sp. z o.o. /ID# 247376	Katowice	Slaskie
Poland	Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298	Lublin	Lubelskie
Poland	Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315	Oswiecim	Malopolskie
Poland	Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323	Poznan	Wielkopolskie
Poland	Solumed Centrum Medyczne /ID# 247317	Poznan	Wielkopolskie
Poland	RCMed Oddzial Sochaczew /ID# 247378	Sochaczew	Mazowieckie
Poland	ETG Neuroscience Sp. z o.o. /ID# 247331	Warszawa	Mazowieckie
Portugal	Hospital Garcia de Orta /ID# 247163	Almada	Setubal
Portugal	2CA-Braga, Hospital de Braga /ID# 247165	Braga
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 247167	Lisboa
Portugal	Hospital da Luz Lisboa /ID# 247168	Lisboa
Portugal	Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172	Lisboa
Portugal	Unidade Local de Saúde de Matosinhos, EPE /ID# 247169	Matosinhos
United Kingdom	West Walk Surgery /ID# 252855	Bristol	Bristol, City Of
United Kingdom	NHS Greater Glasgow and Clyde /ID# 247979	Glasgow	Scotland
United Kingdom	The Adam Practice /ID# 248880	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Portugal,  United Kingdom, 

Outcome

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

External Links

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