This excerpt taken from the TPTX 8-K filed Oct 22, 2007.
A total of 306 patients were randomly assigned to receive a single, subcutaneous dose of 40 mg, 70 mg or 100 mg of tezampanel or placebo to treat one acute migraine attack. The primary endpoint of the study was headache pain response two hours post-dose, defined as a reduction of migraine pain from severe or moderate to mild or none as measured by the International Headache Society 4-point rating scale.
For the primary endpoint, a statistically significant improvement in headache pain response was observed in 78.2 percent of patients at the 40 mg dose compared to 58.7 percent of patients receiving placebo (p=0.033 corrected for multiplicity by the Hochberg procedure; p=0.011 not corrected for multiplicity). The treatment effect for the 70 mg and 100 mg dose groups did not achieve statistical significance. A total of 63.5 percent of patients at the 70 mg dose (p=0.890 corrected; p=0.577 not corrected) and 57.1 percent of patients at the 100 mg dose (p=0.890, no correction required) reported improvement in headache pain response.
TorreyPines believes that four endpoints measured at two hours post-dose will be required for approval of a treatment for migraine: headache response (the primary endpoint of this study), nausea, photophobia and phonophobia. In this study, the 40 mg dose of tezampanel achieved the following: headache response p=0.033; nausea p=0.014; photophobia p=0.056; phonophobia p=0.227. The last three p-values are not corrected for multiplicity.
Across all doses, treatment with tezampanel was well tolerated with no reports of serious or medically important adverse events. At the 40 mg dose, the most commonly reported adverse events compared to placebo were: injection site pain (5.1 percent versus 20 percent); injection site burning (3.8 percent versus 6.7 percent); dizziness (6.4 percent versus 5.3 percent); somnolence (7.7 percent versus 6.7 percent); and dry mouth (2.6 percent versus 5.3 percent). There was no difference in any dose group compared to placebo in the number of reports of vision-related adverse events.