Topical Intra-Oral Ketoprofen for Migraine Prevention
| Status: | Archived |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | March 2011 |
Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.
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.
We found this trial at
1
site
New York Medical College The College was founded in 1860 by a group of New...
Click here to add this to my saved trials
