Clinical trial NCT05748483: Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Episodic migraine
Chronic migraine
Atogepant
Topiramine
QULIPTA
Migraine prophylaxis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
timeFrame: Up to Week 24 (Double-blind treatment period)
Secondary outcomes:
measure: Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.
timeFrame: Month 4 to Month 6 (Double-blind treatment period)
measure: Change From Baseline in Mean Monthly Migraine Days
timeFrame: Month 4 to Month 6 (Double-blind treatment period)
measure: Change from Baseline in HIT-6 (Headache Impact Test) Total Score
timeFrame: At Week 24
measure: Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
timeFrame: At Week 24
measure: Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC)
timeFrame: At Week 24
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function -Abilities Subset -Short Form 6a Version 2.0 score.
timeFrame: At Week 6
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Konventhospital Barmherzige Brueder Linz /ID# 247217
state: Oberoesterreich
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 247213
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 247119
state: Wien
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 246959
state: Bruxelles-Capitale
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis /ID# 246954
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent /ID# 246957
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 246962
city: Liege
country: Belgium
facility: CHR de la Citadelle /ID# 246964
city: Victoria
country: Canada
facility: Vancouver Island Health Authority /ID# 247733
state: British Columbia
city: Halifax
country: Canada
facility: Maritime Neurology /ID# 247728
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited /ID# 247727
state: Ontario
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o. /ID# 245924
state: Ostrava-mesto
city: Plzen
country: Czechia
facility: A-Shine s.r.o. /ID# 245923
state: Plzensky Kraj
city: Prague
country: Czechia
facility: Praglandia /ID# 247511
state: Praha 5
city: Hradec Kralove
country: Czechia
facility: NeuroHK s.r.o. /ID# 247500
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s. /ID# 249017
city: Prague 10
country: Czechia
facility: Clintrial s.r.o. /ID# 245926
city: Prague
country: Czechia
facility: Pratia Prague s.r.o. /ID# 245925
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 249016
city: Praha
country: Czechia
facility: INEP medical s.r.o. /ID# 245927
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 247562
state: Rhone
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 247561
city: Paris
country: France
facility: AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 249244
city: Boeblingen
country: Germany
facility: Studienzentrum fuer Neurologie und Psychiatrie /ID# 249236
state: Baden-Wuerttemberg
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 246043
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Neuropoint GmbH /ID# 246038
state: Baden-Wuerttemberg
city: Unterhaching
country: Germany
facility: Neuropraxis Muenchen Sued /ID# 246045
state: Bayern
city: Hoppegarten
country: Germany
facility: Gesundheitszentrum Hoppegarten /ID# 249242
state: Brandenburg
city: Bad Homburg
country: Germany
facility: Praxis fuer Neurologie, Psychiatrie und Psychotherapie /ID# 248427
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Kopfschmerzzentrum - Frankfurt /ID# 248686
state: Hessen
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH /ID# 248074
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH /ID# 248565
state: Niedersachsen
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 246039
state: Niedersachsen
city: Siegen
country: Germany
facility: ZNS Siegen /ID# 251180
state: Nordrhein-Westfalen
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier /ID# 248564
state: Rheinland-Pfalz
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 246030
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040
state: Sachsen
city: Leipzig
country: Germany
facility: Ambenet Hausarztpraxis /ID# 246028
state: Sachsen
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 246037
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Neurologisches Facharztzentrum Berlin /ID# 248064
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 246029
city: Bielefeld
country: Germany
facility: NeuroZentrum Bielefeld /ID# 250758
city: Erbach
country: Germany
facility: Neuro Centrum Odenwald /ID# 248067
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 246033
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald /ID# 248574
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH /ID# 248620
city: Kassel
country: Germany
facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar /ID# 248085
city: Stuttgart
country: Germany
facility: Lewis Neurologie /ID# 250498
city: Budapest
country: Hungary
facility: MIND Clinic /ID# 247867
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 247868
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 248428
city: Budapest
country: Hungary
facility: S-Medicon Kft /ID# 247682
city: Debrecen
country: Hungary
facility: Debreceni Egeszsegugyi Kozpontja /ID# 247549
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 247258
state: H_efa
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 247260
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 247261
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 247259
state: Yerushalayim
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 247575
state: Firenze
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 247576
state: Napoli
city: Rome
country: Italy
facility: IRCCS San Raffaele /ID# 247573
state: Roma
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 247578
city: Pavia
country: Italy
facility: Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 247579
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 247580
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski Sp.j. /ID# 247314
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Athleticomed Sp. z o.o /ID# 250790
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247298
state: Lubelskie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Dr Boczarska Jedynak /ID# 247315
state: Malopolskie
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew /ID# 247378
state: Mazowieckie
city: Warsaw
country: Poland
facility: ETG Neuroscience Sp. z o.o. /ID# 247331
state: Mazowieckie
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. /ID# 247376
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 247317
state: Wielkopolskie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247323
state: Wielkopolskie
city: Almada
country: Portugal
facility: Hospital Garcia de Orta /ID# 247163
state: Setubal
city: Braga
country: Portugal
facility: 2CA-Braga, Hospital de Braga /ID# 247165
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa /ID# 247168
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 247167
city: Lisboa
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca, EPE /ID# 247172
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 247169
city: Poole
country: United Kingdom
facility: The Adam Practice /ID# 248880
state: Dorset
city: Glasgow
country: United Kingdom
facility: Duplicate_NHS Greater Glasgow and Clyde /ID# 247979
state: Scotland
city: Bristol
country: United Kingdom
facility: West Walk Surgery /ID# 252855
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: