A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 620
- 试验地点
- 94
- 主要终点
- Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
研究概览
简要总结
Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).
详细描述
Study 20170703 is a phase 4, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the safety and efficacy of erenumab against placebo in a CM population with MOH and prior history of treatment failure. Participants will be enrolled based on fulfilment of the International Classification of Headache Disorders, 3rd Edition (ICHD-3) CM and MOH criteria and will not be advised to early discontinue acute medication.
Participants who successfully complete the 24-week double-blind treatment period (DBTP) of the study will be offered an opportunity to continue in an open-label treatment period (OLTP) of 28-weeks duration. Participants who received erenumab treatment during the DBTP will continue to receive the same erenumab dose during the OLTP. Participants who received placebo during the DBTP will be allocated in a 1:1 ratio to receive either erenumab 70 mg or 140 mg SC QM during the OLTP. All participants will remain blinded to their original DBTP treatment assignment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
干预措施: Placebo (Drug)
Erenumab 70 mg
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
干预措施: Erenumab 70 mg (Drug)
Erenumab 140 mg
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
干预措施: Erenumab 140 mg (Drug)
结局指标
主要结局
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
时间窗: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) \< 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days \< 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP))
- Number of Participants With Sustained MOH Remission at Month 6(Month 3 (week 12) to month 6 (week 24) of the DBTP)
- Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)(Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP)
- Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID(Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP)
- Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6(Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP)