The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.

Official Title
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A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine

Conditions
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Migraine Disorders, Migraine Headache, Migraine, Acute Migraine

Intervention / Treatment
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* Drug: Topical, intra-oral ketoprofen gel
* Other: Placebo gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established diagnosis of Migraine as per IHS with aura Established diagnosis of Migraine as per IHS without aura At least 2 migraines per month At least 18 years of age Exclusion Criteria: Pregnancy or Lactation Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines Chronic Daily Headache Allergy or Sensitivity to NSAIDs Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical, intra-oral ketoprofen gel<br> | Drug: Topical, intra-oral ketoprofen gel<br>* Ketoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.<br>|
| Placebo Comparator: Placebo gel<br> | Other: Placebo gel<br>* Placebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment |  | Within 240 minutes post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals |  | Within 240 minutes post-treatment | 
| Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals |  | Within 240 minutes post-treatment | 
| Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment |  | Within 240 minutes post-treatment | 
| Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment |  | Within 240 minutes post-treatment | 
| Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment |  | Within 240 minutes post-treatment | 
| Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment |  | Within 240 minutes post-treatment | 
| Need for Rescue Medication between the time of dosing to 240 minutes |  | Within 240 minutes post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Migraine Treatment, Migraine Treatment, Migraine, Headache, Treatment