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Evaluation of MIG-SPRAY Treatment on Migraine

NCT07100496 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

MIG-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 & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Gisèle PICKERING, · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100496 on ClinicalTrials.gov