TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
TorreyPinesTherapeutics, Inc. recently announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine headache. Tezampanel is an AMPA/kainate (AK) receptor antagonist that offers a non-opioid, non-vascular and non-serotonergic approach to the management of pain and represents a potentially new and promising alternative to current migraine treatments.
The clinical trial is a double-blind, placebo-controlled, multi-center trial that reached its targeted enrollment of 300 patients suffering a single migraine attack, with or without aura. Patients are randomized to one of four arms and receive a 40 mg, 70 mg, or 100 mg single, subcutaneous dose of tezampanel or placebo. 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 in acute migraine. The primary efficacy end point for the trial is headache pain relief at two hours post-dose. Secondary efficacy end points include pain free status at two hours, sustained pain relief and sustained pain free at 24 hours, and headache recurrence and relapse. Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, photophobia (sensitivity to light) and phonophobia(sensitivity to sound), as well as various assessments that characterizes peed of treatment onset. Safety, tolerability and plasma pharmacokinetic data will also be evaluated.
In previous clinical trials, tezampanel has been administered to more than 200 healthy adult volunteers or patients. In five Phase IIa, placebo-controlled trials using intravenous administration, tezampanel demonstrated proof of concept in multiple pain models. In one placebo and active-controlled clinical trial in patients with acute migraine, the compound achieved statistical significance in all primary and secondary end points traditionally required for regulatory approval. These end points included pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia.
For more information, visit torreypinestherapeutics.com.
The clinical trial is a double-blind, placebo-controlled, multi-center trial that reached its targeted enrollment of 300 patients suffering a single migraine attack, with or without aura. Patients are randomized to one of four arms and receive a 40 mg, 70 mg, or 100 mg single, subcutaneous dose of tezampanel or placebo. 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 in acute migraine. The primary efficacy end point for the trial is headache pain relief at two hours post-dose. Secondary efficacy end points include pain free status at two hours, sustained pain relief and sustained pain free at 24 hours, and headache recurrence and relapse. Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, photophobia (sensitivity to light) and phonophobia(sensitivity to sound), as well as various assessments that characterizes peed of treatment onset. Safety, tolerability and plasma pharmacokinetic data will also be evaluated.
In previous clinical trials, tezampanel has been administered to more than 200 healthy adult volunteers or patients. In five Phase IIa, placebo-controlled trials using intravenous administration, tezampanel demonstrated proof of concept in multiple pain models. In one placebo and active-controlled clinical trial in patients with acute migraine, the compound achieved statistical significance in all primary and secondary end points traditionally required for regulatory approval. These end points included pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia.
For more information, visit torreypinestherapeutics.com.
Labels: acute migraine headache
posted by Ron King at 2:33 PM
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