The Phase IIb trial was an in-clinic evaluation of tezampanel in patients suffering a single migraine attack, with or without aura. The clinical trial was designed as a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial.
The primary purpose of the trial was to identify a dose that could be used in a Phase III development program for tezampanel in acute migraine. The primary efficacy endpoint was headache pain response at two hours post-dose. Across all doses, treatment with tezampanel was well tolerated with no reports of serious or medically important adverse events. Secondary efficacy endpoints included the traditional endpoints associated with acute migraine trials.
For the primary endpoint, a statistically significant improvement in headache pain response was observed in 78.2% of patients at the 40mg dose compared to 58.7% of patients receiving placebo.
Neil Kurtz, president and CEO of TorreyPines, said: “These data demonstrate that tezampanel unequivocally relieved migraine pain at a dose that is safe and well-tolerated. We look forward to meeting with the FDA to discuss advancing tezampanel into a Phase III trial in 2008.”