Topical Intra-Oral Ketoprofen for Migraine Prevention

Behar, Caren, M.D.

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Other: Placebo Gel; Drug: topical intraoral ketoprofen gel

Study type: Interventional

Identifiers

NCT01211795

IND 79,629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Topical Ketoprofen gel

Active Comparator group

Treatment:

Drug: topical intraoral ketoprofen gel

Placebo gel

Placebo Comparator group

Treatment:

Other: Placebo Gel