2022-501172-25-00
Active, not recruiting
Phase 3
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)
Abbvie Deutschland GmbH & Co. KG69 sites in 7 countries475 target enrollmentStarted: September 8, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 475
- Locations
- 69
- Primary Endpoint
- The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period
Overview
Brief Summary
To evaluate the tolerability and safety of atogepant compared to the highest tolerated dose of topiramate in participants who require preventive treatment of migraine.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Safety Follow-Up Period
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period
The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period
Secondary Outcomes
- Achievement of ≥ 50% improvement (reduction) in mean MMD during Months 4 to 6 of the DB treatment period.
- Change from baseline in mean MMD during Months 4 to 6 of the DB treatment period
- Change from baseline in HIT-6 total score at Week 24
- Change from baseline in MSQ Version 2.1 RFR domain score at Week 24
- Achievement of a rating of "much better" or "very much better" at Week 24 assessed by the PGIC
- 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
Investigators
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
Study Sites (69)
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