TorreyPines Therapeutics Completes Enrollment in Phase IIb Tezampanel Trial
TorreyPines Therapeutics announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine headache.
According to TorreyPines, the clinical trial is a double-blind, placebo-controlled, multicenter trial that has reached its target enrollment of 300 patients.
Patients are randomized to one of four arms and receive a 40-, 70- or 100-mg single, subcutaneous dose of tezampanel or placebo, the company said.
The purpose of the trial is to identify a dose, or a range of doses, that could be used in a Phase III development program for tezampanel, the company added.
According to the company, the primary efficacy endpoint for the trial is headache pain relief at two hours after dosage. Secondary efficacy endpoints include pain-free status at two hours, sustained pain relief and sustained pain-free at 24 hours and headache recurrence and relapse, the company added.
Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, sensitivity to light and sensitivity to sound, as well as various assessments that characterize speed of treatment onset, according to the company.
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