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
- 已完成
- 发起方
- 入组人数
- 545
- 试验地点
- 162
- 主要终点
- Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Atogepant
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
干预措施: Placebo for Topiramate (Drug)
Atogepant
Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
干预措施: Atogepant (Drug)
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
干预措施: Atogepant (Drug)
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
干预措施: Placebo for Atogepant (Drug)
Topiramate
Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
干预措施: Topiramate (Drug)
结局指标
主要结局
Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
时间窗: 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.
Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
时间窗: Week 24
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable.
次要结局
- 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)
- Percentage of Participants Achieving ≥ 50% Improvement (Reduction) in Mean Monthly Migraine Days (MMD) During Months 4 to 6 (DB Period)(Months 4 to 6 (DB Period))
- Change From Baseline in Mean Monthly Migraine Days During Months 4 to 6 (DB Period)(Baseline to Month 4 to Month 6 (DB Period))
- Change From Baseline in the Total 6-Item Headache Impact Test (HIT-6) Score at Week 24(Baseline to Week 24)
- Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Week 24(Baseline to Week 24)
- Percentage of Participants Achieving a Rating of "Much Better" or "Very Much Better" Assessed by the Patient Global Impression of Change (PGIC)(Week 24)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Subset - Short Form 6a Version 2.0 Score(Baseline to Week 6)