ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced the completion of enrollment in its ongoing pivotal Phase III trial with pimavanserin in patients with Parkinson's disease psychosis (PDP). Top-line results from this trial are expected to be announced by the end of November 2012.
The Phase III trial, referred to as the -020 Study, is a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with PDP. The -020 Study incorporates several design enhancements that were guided by previous data in ACADIA's PDP program. A total of 198 patients have been enrolled in the study and were randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks. The primary endpoint of the -020 Study is antipsychotic efficacy as measured using nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms, or SAPS. An independent group of centralized raters is used to assess the primary endpoint in the study. Motoric tolerability is a key secondary endpoint in the study and is measured using Parts II and III of the Unified Parkinson's Disease Rating Scale, or UPDRS.
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