A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-2 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 986
- 试验地点
- 53
- 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 main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic 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)
盲法说明
Sponsor is also masked.
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
- •Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD.
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.
- •Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
- •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) defined by IHS ICHD-3 beta.
研究组 & 干预措施
Galcanezumab 120mg
Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.
干预措施: Galcanezumab (Drug)
Galcanezumab 240mg
Galcanezumab 240mg given by SC injection once a month for 6 months.
干预措施: Galcanezumab (Drug)
Placebo
Placebo given by SC injection once a month for 6 months.
干预措施: Placebo (Drug)
Galcanezumab 120mg Maximum Extended Enrollment Cohort
Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.
干预措施: Galcanezumab (Drug)
Galcanezumab 240mg Maximum Extended Enrollment Cohort
Galcanezumab 240mg given by SC injection once a month for 6 months.
干预措施: Galcanezumab (Drug)
Placebo Maximum Extended Enrollment Cohort
Placebo given by SC injection once a month for 6 months.
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 6
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.
次要结局
- Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days(Baseline, Month 1 through Month 6)
- Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain(Baseline, Month 4 through Month 6)
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache(Baseline, Month 1 through Month 6)
- Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating(Baseline, Month 4 through Month 6)
- Overall Mean Change From Baseline in Headache Hours(Baseline, Month 1 through Month 6)
- Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 6)
- Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab(Month 1 through Month 6)
- Pharmacokinetics (PK): Serum Concentrations of Galcanezumab(Month 6)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Month 6)