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 severityChange 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
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