Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
- Conditions
- Migraine
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 545
- 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.
- 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)
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
Universitair Ziekenhuis Brussel /ID# 246959
🇧🇪Jette, Bruxelles-Capitale, Belgium
Jessa Ziekenhuis /ID# 246954
🇧🇪Hasselt, Limburg, Belgium
UZ Gent /ID# 246957
🇧🇪Gent, Oost-Vlaanderen, Belgium
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
Scroll for more (71 remaining)Konventhospital Barmherzige Brueder Linz /ID# 247217🇦🇹Linz, Oberoesterreich, Austria