MAP Pharmaceuticals recently completed patient enrollment in the efficacy (effectiveness) part of its initial Phase 3 clinical trial testing the orally inhaled MAP0004, used for acute Migraine attacks.
850 Migraineurs are evaluating the effectiveness and safety of MAP0004 in the Phase 3 clinical trial which is a multi-center, double-blind, randomized, placebo-controlled trial.
The primary effectiveness goals are:
- pain relief at two hours after dosing
- suppression of nausea at two hours after dosing
- suppression of photophobia (sensitivity to light) at two hours after dosing
- suppression of phonophobia (sensitivity to sound) at two hours after dosing.
This trial will also to evaluate:
- the earliest time of pain relief
- pain relief at 10 minutes
- sustained pain relief at 24 and 48 hours.
In addition, patients in this study are being looked at for treatment of a single Migraine and may follow up on the long-term safety part of the trial where the enrollment is still on going.
MAP0004 is an orally inhaled medication in development, dispensed by MAP's proprietary TEMPO (R) inhaler. This is the "next generation" of metered dose inhalers delivering medication more consistently and effectively. MAP0004's active ingredient is dihydroergotamine, the same active ingredient that is in Migranal Nasal Spray that is used to abort Migraines. This medication may have faster and longer pain relief than other medications available, is non-invasive and easy to use. So far the data has not shown any serious adverse events and seems to be well tolerated by the participants.
With 36 million Migraineurs in the United States alone, another treatment for acute Migraines would be wonderful news. We look forward to hearing the outcome of this study.
You can read more about MAP0004 in Teri Robert's article MAP0004 Shows Promise for Aborting Migraines.
"MAP Pharmaceuticals Announces Completion of Enrollment in Phase 3 Clinical Trial of MAP0004 in Patients with Migraine." PR Newswire. Mountainview, California. January, 26, 2009.
© Nancy Bonk, 2009
Published On: January 30, 2009