Trial | NCT01211795  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ketoprofen ...

  • Study Participants

    67
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.
Study Started
Oct 31
2009
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Jun 08
2011
Estimate

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.

Topical Ketoprofen gel Active Comparator

Placebo gel Placebo Comparator

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
No Results Posted