Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,026
- 试验地点
- 40
- 主要终点
- Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.
详细描述
Intervention Model: Parallel Versus Comparator + Placebo
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with at least 1-year history of migraines (with or without aura) including the following:
- •Migraine attacks more than 1 year with age of onset prior to 50 years of age
- •Migraine attacks, on average, last about 4 - 72 hours if untreated
- •No more than 8 attacks of moderate to severe intensity per month within last 3 months
- •Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
- •Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
- •Male and female ≥ 18 years and ≤ age 65
- •No clinically significant abnormality identified on the medical or laboratory evaluation
排除标准
- •Patient has a history of basilar migraine or hemiplegic migraine
- •Patient does not receive migraine relief from triptan migraine treatment
- •Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
- •History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
- •History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
研究组 & 干预措施
Treatment B: Rimegepant, 25 mg
Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment A: Rimegepant, 10 mg
Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment A: Rimegepant, 10 mg
Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment B: Rimegepant, 25 mg
Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment C: Rimegepant, 75 mg
Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment C: Rimegepant, 75 mg
Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment D: Rimegepant, 150 mg
Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment D: Rimegepant, 150 mg
Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment E: Rimegepant, 300 mg
Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment E: Rimegepant, 300 mg
Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment F: Rimegepant, 600 mg
Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Rimegepant (Drug)
Treatment F: Rimegepant, 600 mg
Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment P: Rimegepant Placebo-Matching Capsules
Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment G: Sumatriptan 100 mg
Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
干预措施: Placebo (Drug)
Treatment G: Sumatriptan 100 mg
Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
干预措施: Sumatriptan (Drug)
结局指标
主要结局
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
时间窗: Baseline, 2 hours post-dose
Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.
次要结局
- Number of Participants With Total Migraine Freedom at 2 Hours Post Dose(Baseline, 2 hours post dose)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events(AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).)
- Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose(2 hours to 24 hours post dose)
- Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose(2 hours to 48 hours post dose)