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Topical Intra-Oral Ketoprofen for Migraine Prevention

Information source: Behar, Caren, M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: topical intraoral ketoprofen gel (Drug); Placebo Gel (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Behar, Caren, M.D.

Official(s) and/or principal investigator(s):
Caren Behar, MD, Principal Investigator, Affiliation: New York Medical College

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Change in number of migraine days per month

Secondary outcome:

Change in migraine severity

Change in migraine duration

Change in headache medication use

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

New York Medical College, Valhalla, New York 10595, United States
Additional Information

Starting date: October 2009
Last updated: June 4, 2011

Page last updated: August 23, 2015

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