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)

Conditions

Chronic and Episodic Migraine

Brief summary

The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period

Detailed description

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

Reuter U, Dycke AV, Versijpt J, Holle-Lee D, Farkas MK, Tepper SJ, Forero G, Luo L, Guo H, Cohen E, Dabruzzo B, Gandhi P, Nagy K.

2026-07-23

10.1016/s1474-4422(26)00214-0

Interventions

DRUGPlacebo for atogepant tablets 60mg

DRUGTOPIRAMATE

DRUGAtogepant

DRUGPlacebo for topiramate capsules 25mg and 50mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Portugal

Outcome results

None listed