A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 778
- 试验地点
- 150
- 主要终点
- Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
研究概览
简要总结
This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
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
- Triple (Participant, Care Provider, Investigator)
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
- •At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
- •Age of the participant at the time of migraine onset < 50 years
- •Confirmation of headache/migraine headache day frequency as follows:
- •History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
- •>=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
- •>=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
- •Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
排除标准
- •Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
- •Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
- •History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
- •Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.
研究组 & 干预措施
Placebo
Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
干预措施: Placebo (Drug)
Atogepant 30 mg BID
Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
干预措施: Atogepant 30 mg (Drug)
Atogepant 30 mg BID
Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
干预措施: Placebo (Drug)
Atogepant 60 mg QD
Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.
干预措施: Atogepant 60 mg (Drug)
Atogepant 60 mg QD
Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
时间窗: Baseline to Week 12
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
时间窗: Baseline to Week 12
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.
次要结局
- Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population(Baseline to Week 12)
- Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population(Baseline to Week 12)
- Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population(Baseline to Week 12)
- Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population(Baseline to Week 12)
- Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population(Baseline to Week 12)
- Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population(Baseline to Week 12)
- Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population(Baseline to Week 12)
- Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population(At Week 12)
- Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population(Baseline to Week 12)
- Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population(At Week 12)