A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 32
- 主要终点
- Reduction in Migraine Days
研究概览
简要总结
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.
The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.
The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).
详细描述
Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM stimulate endogenous analgesic mechanism. Treatments are self-administered by the user at the onset of a migraine attack. this study intends to demonstrate the safety and efficacy of the Nwrivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter trial, conducted in three phases. The ratio between treatment and control groups will be 1:1, stratified by center and patient type (chronic/non-chronic). The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase. Eligible participants will enter an 8-week double-blind preventive treatment phase. Following the preventive treatment phase, patients will be offered to participate in a 4-week open-label pre-emptive treatment phase or continue their prevention treatment with an active device, according to their eligibility.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow up pre-emptive phase
Phase I - Baseline - 4 weeks (weeks 1 through 4):
Eligible participants will install the Nerivio app on their smartphones and will be instructed to record daily their migraine/headaches symptoms and medication use on the Nerivio app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old.
- •Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
- •History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
- •Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
- •Have personal access to a smartphone (24/7).
- •Must be able and willing to comply with the protocol.
- •Must be able and willing to provide informed consent..
排除标准
- •An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- •Uncontrolled epilepsy.
- •History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
- •Current participation in any other interventional clinical study
- •Subject without basic cognitive and motor skills required for operating a smartphone.
- •Pregnant or breastfeeding.
- •Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- •Prior experience with the Nerivio device.
结局指标
主要结局
Reduction in Migraine Days
时间窗: 3 months
The mean reduction in the number of migraine days per month during the last 28 days (4 weeks) of the treatment phase (weeks 9 through 12) compare to the 4-week baseline phase (weeks 1 through 4) A migraine day is defined as a calendar day with a headache that is accompanied by at least one of the following symptoms: aura, photophobia, phonophobia, nausea and/or vomiting; or a calendar day with a headache that is treated with a migraine-specific acute medication.
Rate of Adverse Events (Safety and Tolerability)
时间窗: 3 months
Number of participants with Adverse Events (AE), Serious Adverse Events (SAE) and Device-related Adverse Events
次要结局
- Reduction in Moderate/Severe Headache Days(3 months)
- Reduction of 50% in Headache Days(3 months)
- Increase in Headache Impact Test-6 (HIT-6) Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the HIT-6 Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)(3 months)
- Reduction in Migraine-Specific Quality-of-Life (MSQ) Questionnaire Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the MSQ Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4)(3 months)
- Reduction Headache Days(3 months)