Topical Intra-Oral Ketoprofen for Migraine Prevention

• Change in migraine severity [ Time Frame: 3 month total ] [ Designated as safety issue: No ]
  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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Average migraine duration will be compared prior to gel use, and at the end of 3 months
• Change in headache medication use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Change in headache medication use will be compared prior to gel use, and at the end of 3 months

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.

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.

• Drug: topical intraoral ketoprofen gel
  20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.
• Other: Placebo Gel
  An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.

• Active Comparator: Topical Ketoprofen gel
  Intervention: Drug: topical intraoral ketoprofen gel
• Placebo Comparator: Placebo gel
  Intervention: Other: Placebo Gel

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