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:

1. Tolerability (primary outcome).
2. 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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).