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NCT Number: NCT07100496

Evaluation of MIG-SPRAY Treatment on Migraine

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Clermont-ferrand

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. The composite score of expected adverse events

    Time frame: 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 outcomes

  1. Unexpected adverse events

    Time frame: 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

  2. Number of migraine

    Time frame: 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.

  3. Measurement of the Migraine Disability Assessment (MIDAS)

    Time frame: 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).

  4. Measurement of the Migraine Disability Assessment (MIDAS)

    Time frame: day 90

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: MIG-S

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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