BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 813
- 试验地点
- 185
- 主要终点
- Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
研究概览
简要总结
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
详细描述
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- •Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
- •4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
- •Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
- •Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
- •Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- •Triptan unsuitable
排除标准
- •Target Disease Exclusion:
- •History of cluster headache, basilar migraine, or hemiplegic migraine
- •Current medication overuse headaches
- •Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
- •Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
- •Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
研究组 & 干预措施
Rimegepant
Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT)
Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
干预措施: Rimegepant (Drug)
Placebo
Placebo - Double-blind (DB) Phase: One dose of matching placebo
Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine
干预措施: Placebo (Drug)
Placebo
Placebo - Double-blind (DB) Phase: One dose of matching placebo
Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine
干预措施: Rimegepant (Drug)
结局指标
主要结局
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
时间窗: 2 hours post-dose
Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase
时间窗: At 2 hours post-dose
Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief at 2 hours post-dose was defined as pain intensity of none or mild at that time point.
次要结局
- Percentage of Participants With Pain Freedom at 2 Hours Post-Dose: DBT Phase(At 2 hours post-dose)
- Percentage of Participants Who Used Rescue Medications Within 24 Hours Post-Dose: DBT Phase(Within 24 hours post-dose)
- Percentage of Participants With Return to Normal Function at 2 Hours Post-Dose: DBT Phase(At 2 hours post-dose)
- Percentage of Participants With Sustained Return to Normal Function From 2 to 24 Hours Post-Dose: DBT Phase(From 2 to 24 hours post-dose)
- Percentage of Participants With Sustained Return to Normal Function From 2 to 48 Hours Post-Dose: DBT Phase(From 2 to 48 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose: DBT Phase(From 2 to 24 hours post-dose)
- Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose: DBT Phase(From 2 to 48 hours post-dose)
- Percentage of Participants With Sustained Freedom From Pain From 2 to 24 Hours Post-Dose: DBT Phase(From 2 to 24 hours post-dose)
- Percentage of Participants With Sustained Freedom From Pain From 2 to 48 Hours Post-Dose: DBT Phase(From 2 to 48 hours post-dose)
- Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose: DBT Phase(At 2 hours post-dose)
- Reliability of Rimegepant Effect in the OLE Phase Based on Evaluable Qualifying Migraine Attacks (EQMA) of DBT and OLE Phase(DBT phase: up to maximum 45 days; OLE phase: up to maximum of 12 weeks)
- Mean Change From Historical Baseline in Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase(Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days))
- Percentage of Participants With at Least 50% Reduction From Historical Baseline in the Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase(Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days))
- Number of Participants With Adverse Events (AEs) by Intensity: DBT Phase(DBT Phase: maximum of 45 days)
- Number of Participants With Serious AEs: DBT Phase(DBT Phase: maximum of 45 days)
- Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase(DBT Phase: maximum of 45 days)
- Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Abnormalities: DBT Phase(DBT Phase: maximum of 45 days)
- Number of Participants With AEs by Intensity: OLE Phase(OLE Phase: maximum up to 12 weeks)
- Number of Participants With Serious AEs: OLE Phase(OLE Phase: maximum up to 12 weeks)
- Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase(OLE Phase: maximum up to 12 weeks)
- Number of Participants With On-Treatment Grade 3 to 4 Laboratory Abnormalities: OLE Phase(OLE Phase: maximum up to 12 weeks)
- Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Weeks 4, 8, and 12: OLE Phase(OLE phase: Baseline; Week 4, Week 8 and Week 12)