MigrainePhase 4MIG-SNCT07100496
Evaluation of MIG-SPRAY Treatment on Migraine
A Phase 4 study testing MIG-SPRAY in people with Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- MIG-SPRAY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2025to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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:
- Tolerability (primary outcome).
- 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
- Being tested
- MIG-SPRAY
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIG-SPRAYCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (MIG-SPRAY) | Experimental | Not described Receives: Combination Product: MIG-SPRAY |
| Control group (no device) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite score of expected adverse events
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.
Measured: From visit 1 (day 1) to the end of treatment (day 90)
Secondary outcomes (4)
Unexpected adverse events
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
Measured: From visit 1 (day 1) to the end of treatment (day 90)
Number of migraine
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.
Measured: From visit 1 (day 1) to the end of treatment (day 90)
Measurement of the Migraine Disability Assessment (MIDAS)
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).
Measured: day 1
Measurement of the Migraine Disability Assessment (MIDAS)
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).
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start15 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING,, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100496
- Sponsor's protocol ID
- RBHP 2024 PICKERING 2
- Other IDs
- 2024-A02815-42
- Acronym
- MIG-S
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MIG-SPRAY Treatment on Migraine
- ClinicalTrials.gov ID
- NCT07100496
- Acronym / sponsor ID
- MIG-S / RBHP 2024 PICKERING 2
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tolerability (primary outcome).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (MIG-SPRAY) | Experimental | Combination Product: MIG-SPRAY |
| Control group (no device) | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIG-SPRAYMIG-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). | Combination product | Intervention group (MIG-SPRAY) |
Primary outcome
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.
4 secondary outcomes
Unexpected adverse events
Time frame: From visit 1 (day 1) to the end of treatment (day 90)
Number of migraine
Time frame: From visit 1 (day 1) to the end of treatment (day 90)
Measurement of the Migraine Disability Assessment (MIDAS)
Time frame: day 1
Measurement of the Migraine Disability Assessment (MIDAS)
Time frame: day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING, principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIG-SPRAY in people with Migraine, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite score of expected adverse events (time frame: From visit 1 (day 1) to the end of treatment (day 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.