NCT02614261已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN 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
- 1,117
- 试验地点
- 58
- 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 evaluate the efficacy of the study drug known as galcanezumab in participants with 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Study:
- •Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age
- •Israel addendum:
- •Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
- •Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.
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
Placebo
Placebo Comparator
- Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
- Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
- Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
干预措施: Galcanezumab (Drug)
Placebo
Placebo Comparator
- Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
- Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
- Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
干预措施: Placebo (Drug)
Galcanezumab 120 mg
Experimental
- Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months.
- Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
- Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
干预措施: Galcanezumab (Drug)
Galcanezumab 240 mg
Experimental
- Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
- Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.
- Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
干预措施: Galcanezumab (Drug)
Israel Addendum
Experimental
Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.
干预措施: Galcanezumab (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 3
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, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
次要结局
- Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain(Baseline, Month 3)
- Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days(Baseline, Month 1 through Month 3)
- Overall Mean Change From Baseline in Headache Hours(Baseline, Month 1 through Month 3)
- 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 3)
- Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 3)
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab(Baseline through Month 3)
- Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score(Baseline, Month 3)
- Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab(Month 1 through Month 3)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Month 3)
- Serum Concentrations of Galcanezumab(Month 3)
研究者
研究点 (58)
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