NCT07100496Active, not recruitingPhase 4
Evaluation of MIG-SPRAY Treatment on Migraine
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Migraine
- NCT number
- NCT07100496
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 45
- From 15 Sept 2025 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hypersensitivity: Known allergy to any component of the investigational product(s), salicylates, or camphor.
- Substance abuse: Current drug dependence or abuse (investigator's judgment).
- Concurrent trials: Participation in another clinical trial, ongoing exclusion period, or receipt of \>€6000 in trial-related compensation in the past 12 months.
Other illness
- Medical incompatibility: Any condition deemed unsafe for participation (investigator's assessment).
Other
- Pregnancy/breastfeeding: Pregnant or lactating women.
- Legal protections: Under legal guardianship, curatorship, or deprivation of liberty.
- Significant medical history: Relevant comorbidities or antecedents (investigator's discretion).
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.