A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 38
- 主要终点
- Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
研究概览
简要总结
The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.
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
- •Participants with a history of migraine of at least 1 year prior to enrollment.
- •Migraine onset prior to age 50.
排除标准
- •Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
- •Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- •History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
- •Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
- •Failure to respond to more than two adequately dosed effective migraine prevention treatments.
- •Evidence of significant active psychiatric disease, in the opinion of the investigator.
- •Women who are pregnant or nursing.
研究组 & 干预措施
5mg Galcanezumab
5mg of galcanezumab given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
干预措施: Galcanezumab (Drug)
50mg Galcanezumab
50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
干预措施: Galcanezumab (Drug)
120mg Galcanezumab
120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
干预措施: Galcanezumab (Drug)
300mg Galcanezumab
300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period.
干预措施: Galcanezumab (Drug)
Placebo
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase
时间窗: Baseline, 12 Weeks
The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-3 beta definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
次要结局
- Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores(Baseline, 12 Weeks)
- Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase(Baseline, 12 Weeks)
- Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase(Week 12)
- Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase(Baseline, 12 Weeks)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(12 Weeks)
- Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab(Baseline through 12 Weeks)
- Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase(Baseline, 12 Weeks)
- Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores(Baseline, 12 Weeks)
- Serum Concentration of Galcanezumab(12 Weeks)
- Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores(Baseline through Week 12)
- Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase(Baseline, 12 Weeks)
- Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase(Baseline, 12 Weeks)