Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07100496 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of MIG-SPRAY Treatment on Migraine

Study acronym: MIG-S
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Site contact updated
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07100496
Lead Sponsor University Hospital, Clermont-Ferrand
Conditions
(from sponsor)
Migraine
Related terms Migraine Disorders
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov