Topical Intra-Oral Ketoprofen for Migraine Prevention

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: topical intraoral ketoprofen gel; Other: Placebo Gel

• Registration Number: NCT01211795
• Lead Sponsor: Behar, Caren, M.D.

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-30
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-04
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Ketoprofen gel	topical intraoral ketoprofen gel	-
Placebo gel	Placebo Gel	-

Primary Outcome Measures

Name	Time	Method
Change in number of migraine days per month	3 months	Number of migraine days per month will be compared before gel use and at the end of 3 months of use.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States