A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in headache intensity
研究概览
简要总结
Researchers are trying to find out more about the side effects of fremanezumab when treating patients with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) for migraine headaches.
详细描述
Subjects will receive 4 to 20 weeks of placebo injections followed by 12 weeks of monthly administered fremanezumab by subcutaneous injection (225 mg split four weeks apart for 12 weeks). Following completion of the 12 weeks of therapy, the participant will return to placebo for the washout period. Both the patient and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 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
Subjects with CADASIL treatment intervention
Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with Fremanezumab injections.
干预措施: Fremanezumab (Drug)
Subjects with CADASIL treatment intervention
Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with Fremanezumab injections.
干预措施: Placebo (Drug)
Subjects with CADASIL placebo intervention
Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with placebo injections.
干预措施: Fremanezumab (Drug)
Subjects with CADASIL placebo intervention
Subjects that have been diagnosed with both CADASIL and moderately to severely disabling migraine headaches will be treated with placebo injections.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in headache intensity
时间窗: Baseline, 2 week intervals up to 48 weeks
Measured using Headache Impact Test (HIT)-6 scores with the answers being never, rarely, sometimes, very often or always and equating to 6, 8, 10, 11, and 13 points respectively. Each answer is summated to equal the final score.
Adverse events
时间窗: 48 weeks
Number of adverse events reported
Change in migraine-related disability
时间窗: Baseline, 2 week intervals up to 48 weeks
Measured using the The Migraine Disability Assessment (MIDAS) questionnaire which is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period using number of days
次要结局
未报告次要终点
研究者
James F. Meschia
Principal Investigator
Mayo Clinic