Evaluation of MIG-SPRAY Treatment on Migraine
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The composite score of expected adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate the real-world tolerability of the MIG-SPRAY device in adults aged 18-55 diagnosed with migraine (according to nternational Classification of Headache Disorders 3rd edition, code 1.1(ICHD-3)) for over 1 year.
The main questions it aims to answer are:
- Does MIG-SPRAY significantly reduce the composite score of expected adverse events (e.g., allergic reactions, nausea, headache) compared to no intervention, graded via a Likert scale (using the Common Terminology Criteria for Adverse Event (CTCAE v5.0))?
- Are there differences in unexpected adverse events, monthly migraine frequency, or Migraine Disability Assessment (MIDAS) scores between groups?
Researchers will compare the intervention group (MIG-SPRAY) to the control group (no device) to assess:
- Tolerability (primary outcome).
- Unexpected adverse events, migraine frequency, and disability (secondary outcomes).
Participants will:
- Be randomized (2:1) to MIG-SPRAY (n=30) or control (n=15).
- Use an electronic diary daily to report adverse events and migraine episodes.
- Complete the MIDAS questionnaire at baseline and post-treatment.
- Undergo monthly physician calls to review and grade adverse events.
Study design:
- Post-marketing, monocentric, open-label, randomized trial (Clermont-Ferrand University Hospital).
- Category 4.2 clinical investigation (CE-marked Class I device, used per labeling).
- No changes to background migraine therapy permitted.
Key eligibility:
- Age 18-55, migraine diagnosis ≥1 year (ICHD-3).
- Effective contraception (females of childbearing potential).
- Social security coverage and written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 55 years
- •Migraine diagnosis for >1 year
- •Meeting ICHD-3 (International Classification of Headache Disorders 3rd edition, code 1.1) diagnostic criteria
- •Effective contraception for females of childbearing potential
- •Sufficient cooperation and understanding to comply with trial requirements
- •Provided informed consent after receiving complete study information
- •Enrolled in the French Social Security system
排除标准
- •Hypersensitivity: Known allergy to any component of the investigational product(s), salicylates, or camphor.
- •Substance abuse: Current drug dependence or abuse (investigator's judgment).
- •Pregnancy/breastfeeding: Pregnant or lactating women.
- •Concurrent trials: Participation in another clinical trial, ongoing exclusion period, or receipt of >€6000 in trial-related compensation in the past 12 months.
- •Legal protections: Under legal guardianship, curatorship, or deprivation of liberty.
- •Medical incompatibility: Any condition deemed unsafe for participation (investigator's assessment).
- •Significant medical history: Relevant comorbidities or antecedents (investigator's discretion).
研究组 & 干预措施
Intervention group (MIG-SPRAY)
干预措施: MIG-SPRAY (Combination Product)
Control group (no device)
结局指标
主要结局
The composite score of expected adverse events
时间窗: From visit 1 (day 1) to the end of treatment (day 90)
The study's primary endpoint is a composite score of adverse events (AEs) recorded during MIG-SPRAY® use. Key Details: - Calculation: Sum of severity grades (1-4 points, Likert scale) for 10 predefined AEs based on published device data: Allergic reaction, nausea, vomiting, dizziness, headache, drowsiness, sneezing, stomach pain, sore throat, and nasal dryness. * Grading: AEs are assessed via CTCAE v5.0 and aggregated into a single composite score. * Data Collection: * Patients report AEs daily via an electronic diary. * Study physicians monthly verify and grade AEs using the predefined Likert scale. Purpose: To quantitatively evaluate MIG-SPRAY®'s tolerability profile during the treatment period.
次要结局
- Number of migraine(From visit 1 (day 1) to the end of treatment (day 90))
- Measurement of the Migraine Disability Assessment (MIDAS)(day 90)
- Unexpected adverse events(From visit 1 (day 1) to the end of treatment (day 90))
- Measurement of the Migraine Disability Assessment (MIDAS)(day 1)