Evaluation of MIG-SPRAY Treatment on Migraine

NCT ID: NCT07100496

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-07-31

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:

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

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group (MIG-SPRAY)

Group Type: EXPERIMENTAL

MIG-SPRAY

Intervention Type: 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).

Control group (no device)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle PICKERING,

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2024-A02815-42

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2024 PICKERING 2

Identifier Type: -

Identifier Source: org_study_id