Topical Intra-Oral Ketoprofen for Migraine Prevention

Last updated: June 4, 2011
Sponsor: Behar, Caren, M.D.
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Headaches

Pain

Treatment

N/A

Clinical Study ID

NCT01211795
IND 79,629
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • IHS Migraine with or without aura

  • 18 y.o. or older

  • at least 4 migraines per month

Exclusion

Exclusion Criteria:

  • pregnancy

  • other headache conditions

  • chronic daily headache

  • allergy or sensitivity to NSAIDs other severe illnesses

Study Design

Total Participants: 67
Study Start date:
October 01, 2009
Estimated Completion Date:
June 30, 2011

Study 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.

Connect with a study center

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

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