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.