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news.Acadia Pharmaceuticals has completed enrollment in its multi-center, double-blind, placebo-controlled Phase IIb clinical trial with ACP-104 in patients with schizophrenia significantly ahead of expectations. Acadia expects to report top-line results from this trial during the second quarter of 2008.
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The study is designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia who are experiencing an acute psychotic episode. A total of 248 patients were enrolled in the trial and randomized to one of three study arms, with patients receiving either of two doses of ACP-104 (100mg or 200mg twice daily) or placebo. Patients receive oral doses of either ACP-104 or placebo for six weeks. The primary endpoint of the trial is antipsychotic efficacy as measured using the Positive and Negative Syndrome Scale (PANSS), an industry standard rating scale commonly used in schizophrenia trials.
Uli Hacksell, CEO of Acadia, said: “We are delighted with the rapid completion of enrollment in our ACP-104 Phase IIb schizophrenia trial and we look forward to reporting results from this exciting proof-of-concept study earlier than previously planned. We believe that the strong interest we have seen from investigators and the accelerated pace of trial enrollment are a reflection of both the critical need for better therapy options and the potential for ACP-104 to improve the standard of care for patients who suffer from this debilitating mental illness.”