Migraine
Conditions
Keywords
Migraine, Prevention, Treatment, Ketoprofen, Trigeminal nerve
Brief 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.
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.
Interventions
DRUGtopical 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.
OTHERPlacebo 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.
Sponsors
Behar, Caren, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of migraine days per month | 3 months | Number of migraine days per month will be compared before gel use and at the end of 3 months of use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in migraine severity | 3 month total | 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 | 3 months | Average migraine duration will be compared prior to gel use, and at the end of 3 months |
| Change in headache medication use | 3 months | Change in headache medication use will be compared prior to gel use, and at the end of 3 months |
Countries
United States
Outcome results
None listed