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news.Teva Pharmaceutical has released results from the Phase II Alstar trial which was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis (ALS) patients. The results indicated that while Talampanel was safe for ALS patients, the study did not meet its primary endpoint.
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The randomised, double-blind, placebo-controlled, parallel-group, Phase II study was conducted in 25 centers across US, Canada, Europe and Israel and included 559 patients with ALS.
In the trial, patients were randomised 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 (83% of patients were on riluzole at the beginning of trial) in combination with Talampanel.
Reportedly, 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.
Moshe Manor, group vice president of global branded products at Teva, said: “Despite our hopes to advance the treatment of this debilitating disease, Talampanel did not succeed in demonstrating the required efficacy, although safety was established.
“Broadening our pipeline through internal R&D, licensing and other business development activities is part of our long term strategy. This outcome has no impact on our 2015 goal.
“We will continue to pursue the development of treatments, focused on the therapeutic areas of neurology, autoimmunity and oncology.”