Phase 3 study of pimavanserin for the treatment of Parkinson's disease psychosis (PDP)
Acadia Pharmaceuticals announced the initiation of its Phase 3 study of pimavanserin for the treatment of Parkinson's disease psychosis (PDP). This trial (the -020 Study) is a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin in 200 patients at clinical sites located in North America.
Patients in the trial will be randomized on a one-to-one basis to two study arms and will receive oral doses of either 40 mg of pimavanserin or placebo once-daily for six weeks. Patients also will continue to receive stable doses of their existing dopamine replacement therapy used to manage the motoric symptoms of Parkinson's disease. The primary endpoint of the -020 Study is antipsychotic efficacy as measured using a group of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS). The primary endpoint will be assessed using centralized ratings. Motoric tolerability will be a key secondary endpoint in the trial and will be measured using Parts II and III of the Unified Parkinson's Disease Rating Scale (UPDRS).
Pimavanserin is a 5-HT2A receptor inverse agonist being developed by Acadia and Biovail as a once-daily oral tablet.For more information call (858) 558-2871 or visit www.acadia-pharm.com.