NCT03559257已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 69
- 主要终点
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
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 or chronic migraine.
- •History of migraine headaches at least 1 year prior to screening, with onset prior to age
- •History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
- •Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.
排除标准
- •Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- •Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
- •History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).
- •Pregnant or nursing.
研究组 & 干预措施
Galcanezumab
Experimental
Galcanezumab administered subcutaneously (SC).
干预措施: Galcanezumab (Drug)
Placebo
Placebo Comparator
Placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
时间窗: Baseline, Month 1 through Month 3
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
次要结局
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine(Baseline, Month 1 through Month 3)
- Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine(Baseline, Month 3)
- Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use(Baseline, Month 1 through Month 3)
- Overall Mean Change From Baseline in the Number of Monthly Headache Days(Baseline, Month 1 through Month 3)
- Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 3)
- Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)(Baseline, Month 3)
- Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)(Baseline, Month 3)
- Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)(Baseline, Month 3)
- Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)(Baseline, Month 3)
- Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S)(Baseline, Month 3)
- Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)(Baseline, Month 3)
- Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score(Baseline, Month 3)
研究者
研究点 (69)
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