A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 3
- 主要终点
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
研究概览
简要总结
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese 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)
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 guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
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 other antibodies to CGRP or its receptor.
- •Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- •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
120 milligrams (mg) Galcanezumab
120 mg galcanezumab (LY2951742) administered subcutaneously (SC) once a month for 6 months.
干预措施: Galcanezumab (Drug)
240 mg Galcanezumab
120 mg galcanezumab (LY2951742) administered SC once a month for 6 months.
干预措施: Galcanezumab (Drug)
Placebo
Placebo administered SC 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 (MHD)
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; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction.
次要结局
- Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 6)
- Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score(Baseline, Month 4 through Month 6)
- Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 6)
- Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 6)
- Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use(Baseline, Month 1 through Month 6)
- Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire(Baseline, Month 4 through Month 6)
- Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days(Baseline, Month 1 through Month 6)
- Overall Mean Change From Baseline in Headache Hours(Baseline, Month 1 through Month 6)
- Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)(Month 6)
- Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab(Baseline through Month 6)
- Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Month 6)
- Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)(Month 1 through Month 6)
- Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)(Month 1 through Month 6)
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab(Month 6)