A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Performance and Safety of the Chordate System When Used in the Treatment of Acute Migraine Attacks of Moderate to Severe Intensity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 18
- 主要终点
- Headache relief
研究概览
简要总结
The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.
详细描述
One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.
After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.
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
- •Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders [ICHD]-III beta).
- •History of 1 to 6 migraine attacks per month for at least 12 previous months.
- •At least 50% of previous migraine attacks had moderate or severe pain intensity.
- •History of at least 48 hours of freedom from headache between migraine attacks.
- •The majority of the previous untreated migraine attacks lasted at least 8 hours.
- •Migraine onset before the age of 50 years.
排除标准
- •History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
- •More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
- •Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
- •Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
- •Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
- •Pronounced anterior septal nasal deviation.
结局指标
主要结局
Headache relief
时间窗: 2 hours after treatment initiation
Percentage of subjects with a decrease in migraine headache pain from severe or moderate prior treatment to mild or none at 2 hours after treatment initiation with no use of rescue medication during this time period.
次要结局
- Frequency, severity, device-relationship and outcome of all adverse events(48 hours post-treatment initiation)
- 24 hour sustained pain-free rate(24 hours after treatment initiation)
- Time to meaningful relief(4 hours post-treatment initiation)
- Subject global impression(48 hours post-treatment initiation.)
- Pain-free rate(2 hours after treatment initiation)
- Incidence of recurrence(48 hours after treatment initiation)
- 48 hour sustained pain-free rate(48 hours after treatment initiation)
- Use of rescue medication(48 hours post-treatment initiation)
- Change in nausea, photophobia, phonophobia, vomiting and disability(2 hours post-treatment initiation)