Evaluation of MIG-SPRAY Treatment on Migraine

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Primary outcome measure(s)

• The composite score of expected adverse events — 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.

Trial sites (1)

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