This excerpt taken from the TPTX 8-K filed Oct 22, 2007.
Clinical Trial Design
This 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. A total of 306 patients were enrolled at 23 centers in the United States. Patients were equally randomized at each center to one of four treatment arms and received 40 mg, 70 mg, or 100 mg of tezampanel or placebo as a single, subcutaneous dose.
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. Secondary efficacy endpoints included the traditional endpoints associated with acute migraine trials. Safety and tolerability data were collected throughout the clinical trial period. Additionally, pharmacokinetic evaluations were completed in a subset of patients through 24 hours post-dose.