Topical Intra-Oral Ketoprofen for Migraine Prevention

Study Overview
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Brief Summary
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Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

Detailed Description
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This is a 4 month trial. During the first month, a prospective headache diary is maintained. Migraine frequency, severity (1-10), duration, and all headache medications are recorded. Patients are then randomized to receive active gel or placebo gel in double blind fashion. Gel is applied to the posterior maxilla once daily for 3 months. A daily headache diary, as outlined above, is maintained throughout the trial. Patients may continue to take other migraine medications, as needed. No other new migraine therapies may be started during the trial.

Official Title
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Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.

Conditions
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Migraine

Intervention / Treatment
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* Drug: topical intraoral ketoprofen gel
* Other: Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IHS Migraine with or without aura 18 y.o. or older at least 4 migraines per month Exclusion Criteria: pregnancy other headache conditions chronic daily headache allergy or sensitivity to NSAIDs other severe illnesses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Ketoprofen gel<br> | Drug: topical intraoral ketoprofen gel<br>* 20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.<br>|
| Placebo Comparator: Placebo gel<br> | Other: Placebo Gel<br>* An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of migraine days per month | Number of migraine days per month will be compared before gel use and at the end of 3 months of use. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in migraine severity | Average migraine severity on a scale of 1-10, will be compared prior to gel use, and at the end of 3 months | 3 month total | 
| Change in migraine duration | Average migraine duration will be compared prior to gel use, and at the end of 3 months | 3 months | 
| Change in headache medication use | Change in headache medication use will be compared prior to gel use, and at the end of 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Prevention, Treatment, Ketoprofen, Trigeminal nerve