Evaluation of MIG-SPRAY Treatment on Migraine

University Hospital, Clermont-Ferrand

Status and phase

Not yet enrolling

Phase 4

Conditions

Migraine

Treatments

Combination Product: MIG-SPRAY

Study type

Interventional

Funder types

Other

Identifiers

NCT07100496

2024-A02815-42 (Other Identifier)

RBHP 2024 PICKERING 2

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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).