Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migrain...(tment arms andreceived 40 mg 70 mg or 10...),Health

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.

Biostatistical Methods

Since this was the first dose-ranging trial for tezampanel in migraine and the first efficacy trial using the subcutaneous route of administration for tezampanel, no a priori assumptions were made regarding the relationship between dose and response. In the pre-specified biostatistical analysis plan, TorreyPines addressed the possibility that any dose could be statistically significant compared to placebo for the primary endpoint. For this endpoint, appropriate corrections were included prospectively in the analytical plan to account for comparisons across dose groups. These corrections made it progressively more difficult to declare significance when multiple comparisons to placebo were performed. In accordance with the protocol-specified analysis plan, the lack of effect at 70 mg and 100 mg did not influence the conclusion that the 40 mg dose demonstrated statistical significance compared to placebo.

Study Results

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
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