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

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

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

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