Teva announced results from its Phase 2 study of talampanel for treatment of amyotrophic lateral sclerosis (ALS). This trial, also known as ALSTAR, was a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study conducted in 25 centers and included 559 patients with ALS. Patients were randomized to receive either talampanel 25mg three times daily, or talampanel 50mg three times daily or placebo orally for a period of 52 weeks. All patients enrolled in the trial were allowed to use riluzole in combination with talampanel.
The primary outcome measure was change from baseline in the revised ALS Functional Rating Scale (ALSFRS-R), a scale for monitoring progression of disability in ALS patients. Results indicate that while talampanel was safe for ALS patients, the study did not meet its primary endpoint.
Talampanel is an orally active antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) neuronal excitatory glutamate receptor.
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