2022-501172-25-00招募中3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 475
- 试验地点
- 69
- 主要终点
- The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period
研究概览
简要总结
To evaluate the tolerability and safety of atogepant compared to the highest tolerated dose of topiramate in participants who require preventive treatment of migraine.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Have used topiramate or atogepant in the past.
- •Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
结局指标
主要结局
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
次要结局
- 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
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (69)
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