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)
Overview
- Phase
- Phase 3
- Intervention
- Atogepant
- Conditions
- Migraine
- Sponsor
- AbbVie
- Enrollment
- 545
- Locations
- 81
- Primary Endpoint
- Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
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.
Arms & Interventions
Atogepant
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Intervention: Atogepant
Atogepant
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Intervention: Placebo for Topiramate
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Intervention: Atogepant
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Intervention: Placebo for Atogepant
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
Intervention: Topiramate
Outcomes
Primary Outcomes
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
Time Frame: 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 Outcomes
- 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))
- Change From Baseline in Mean Monthly Migraine Days(Month 4 to Month 6 (Double-blind treatment period))
- Change from Baseline in HIT-6 (Headache Impact Test) Total Score(At Week 24)
- Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score(At Week 24)
- 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)
- 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)