Evaluation of MIG-SPRAY Treatment on Migraine

NCT07100496 | Active Not Recruiting Phase 4

• 2 other identifiers: RBHP 2024 PICKERING 22024-A02815-42
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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:
• Tolerability (primary outcome).
• Unexpected adverse events, migraine frequency, and disability (secondary outcomes).
• 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

Outcome Measures

Primary Outcomes (1)

• The composite score of expected adverse events

  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.

  From visit 1 (day 1) to the end of treatment (day 90)

Secondary Outcomes (4)

• Unexpected adverse events

  From visit 1 (day 1) to the end of treatment (day 90)

• Number of migraine

  From visit 1 (day 1) to the end of treatment (day 90)

• Measurement of the Migraine Disability Assessment (MIDAS)

  day 1

• Measurement of the Migraine Disability Assessment (MIDAS)

  day 90

Study Arms (2)

Intervention group (MIG-SPRAY)

EXPERIMENTAL

Combination Product: MIG-SPRAY

Control group (no device)

NO INTERVENTION

Interventions

MIG-SPRAY COMBINATION_PRODUCT

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).

Intervention group (MIG-SPRAY)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gisèle PICKERING,

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)