Migraine
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTMIG-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).
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unexpected adverse events | From visit 1 (day 1) to the end of treatment (day 90) | All adverse events (AEs) not previously listed as expected events, reported by patients in both the MIG-SPRAY® and control groups, will be recorded in a daily electronic diary. Key Assessment Criteria: * Any AE with a "possible" causal relationship to the study product (as determined by the investigator) will be classified as treatment-related * These unexpected AEs will be graded (1-4) using the NCI-CTCAE v5.0 Likert scale * A composite score will be calculated by summing the severity grades of all unexpected AEs during the treatment period |
| Number of migraine | From visit 1 (day 1) to the end of treatment (day 90) | Patients will record all migraine episodes in a daily electronic diary throughout the treatment period. Data collection will cover the entire duration of product use. |
| Measurement of the Migraine Disability Assessment (MIDAS) | day 1 | The MIDAS questionnaire quantifies headache-related functional impairment through symptom intensity and quality-of-life impact metrics, categorizing patients into four distinct severity grades (I-IV) based on affected days. This patient-administered instrument facilitates evidence-based treatment stratification, with Grade I indicating minimal disability (0-5 days) and Grade IV representing significant impairment (\>20 days). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGisèle PICKERING,
University Hospital, Clermont-Ferrand
Outcome results
None listed