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news.BioLineRx has initiated a Phase IIb clinical trial to assess the efficacy, safety and tolerability of BL-1020, a GABA-enhanced antipsychotic for the treatment of schizophrenia.
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In this six-week, double-blind, parallel group study, patients will be randomized to one of four arms, receiving a low dose or high dose of BL-1020; risperidone, an approved atypical schizophrenia drug; or placebo.
The study will also include a blinded six weeks continuation Phase in which patients who chose to continue are expected to receive active drugs. It is expected to include 360 schizophrenia patients at approximately 40 sites in the US, Europe, India and Israel and is being conducted under a FDA investigational new drug application.
Morris Laster, CEO of BioLineRx, said: “We are hopeful that BL-1020 could represent a significant advance in the treatment of people suffering from schizophrenia and very much look forward to the results of this Phase IIb study in the third quarter of 2009.”