A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 68
- 主要终点
- Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.
研究概览
简要总结
The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
排除标准
- •Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
- •Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
- •Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
- •Women who are pregnant or nursing
- •Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)
研究组 & 干预措施
Galcanezumab
Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
干预措施: Galcanezumab (Drug)
Galcanezumab
Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
干预措施: Placebo (Drug)
Rimegepant
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
干预措施: Rimegepant (Drug)
Rimegepant
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.
时间窗: Baseline, Month 1 through Month 3
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
次要结局
- Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period.(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1(Baseline, Month 1)
- Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2(Baseline, Month 2)
- Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3(Baseline, Month 3)
- Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period.(Baseline, Month 1 through Month 3)
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period.(Baseline, Month 1 through Month 3)
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Across the 3-month Treatment Period.(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3(Baseline, Month 3)
- Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3(Baseline, Month 3)