A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 20
- 主要终点
- Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
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 chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
- •Participants are able to distinguish cluster headache attacks from other headaches.
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 calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- •Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
- •A history of migraine variants that could implicate or could be confused with ischemia.
- •Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
- •A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
- •Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
- •Women who are pregnant or nursing.
研究组 & 干预措施
Galcanezumab 300 mg
Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
干预措施: Galcanezumab 300 mg (Drug)
Placebo
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
干预措施: Galcanezumab 300 mg (Drug)
Placebo
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
时间窗: Baseline, Week 1 through Week 12
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.
次要结局
- Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks(Baseline, Week 1 through Week 12)
- Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks(Baseline, Week 3 through Week 12)
- Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)(Week 1 through Week 12)
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab(Week 12)
- Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks(Baseline, Week 1 through Week 12)
- Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)(Week 1 through Week 12)
- Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)(Baseline, Week 1 through Week 12)
- Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)(Week 12)