NCT07100496

Evaluation of MIG-SPRAY Treatment on Migraine

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Migraine

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MIG-SPRAY	MIG-SPRAY® is a film-forming liquid dressing designed for the preventive treatment of migraine. Key Features: * Administration: * Applied as 2 sprays per nostril, 3 times daily. * Treatment duration: 3 months. * Mechanism: Forms a protective film on the nasal mucosa, potentially modulating local triggers of migraine. * Use Case: Prophylactic (preventive) therapy for migraine, intended to reduce attack frequency and severity. Additional Notes: * Non-systemic (local action). * CE-marked as a Class I medical device (under EU Directive 93/42/EEC).

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-08-03
• Last updated: 2026-03-18

Locations

1 site across 1 country: France