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New treatment option for Migraine
Official title Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
ClinicalTrials.gov ID: NCT07279623
What this study is testing
- What it's testing
- This is a prospective, randomized, open-label, delayed-start clinical investigation evaluating the safety and efficacy of the Walther System, a Class IIa investigational medical device delivering intra-nasal mechanical stimulation (INMEST), as a preventative treatment for migraine. A total of 110 adults (18-65 years) with a history of migraine will be randomized 1:1 into two groups: Group A (early treatment) and Group B (delayed treatment).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years at the time of screening.
- The study subject must have a clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of...
- Onset of migraine headache occurred before age 50.
- History of migraines for at least 1 year before screening.
- The study subject reports at least 8 monthly migraine days during the screening period.
You likely can't join if
- Subject unable to distinguish between migraine headaches and other headache types.
- Recently (12 months prior screening) undergone nasal or sinus surgery.
- Any severe diseases for which, in the opinion of the Investigator, participation would not be in the best interest of the subject or that can...
- Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
- Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
See the full eligibility criteria
- Age 18-65 years at the time of screening.
- The study subject must have a clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-3)...
- Onset of migraine headache occurred before age 50.
- History of migraines for at least 1 year before screening.
- The study subject reports at least 8 monthly migraine days during the screening period.
- If subject is on a prophylactic migraine medication regimen:
- Reports stable medication regimen during the three months prior to screening.
- Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up.
- The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
- Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.
- Anticipated compliance with prescribed treatment and follow-up.
- Subject unable to distinguish between migraine headaches and other headache types.
- Recently (12 months prior screening) undergone nasal or sinus surgery.
- Any severe diseases for which, in the opinion of the Investigator, participation would not be in the best interest of the subject or that can interfere with the performance, evaluation, and outcome of the clinical...
- Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
- Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
- The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
- The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.