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Acadia announces positive phase 2 trial results for treatment-induced psychosis in Parkinson's patients
By Elaine Rigoli
Tampa, Fla., March 23 - Acadia Pharmaceuticals, Inc. said its phase 2 clinical trial of ACP-103 in patients with Parkinson's disease suffering from treatment-induced psychosis met the primary endpoint of the clinical trial, as it did not worsen motor function.
The trial also evaluated secondary endpoints of antipsychotic efficacy using three different rating scales, and ACP-103 demonstrated antipsychotic effects on two of these rating scales, according to a company news release.
ACP-103 was safe and well tolerated in patients with Parkinson's disease, the release said.
Acadia also provided an update on its ongoing open-label extension study for ACP-103 in patients with Parkinson's disease and reported that some patients have been treated with ACP-103 for over one year, the release said.
The multi-center, double-blind, placebo-controlled study evaluated the motoric tolerability, antipsychotic efficacy and safety of ACP-103 in patients with Parkinson's disease suffering from treatment-induced psychosis.
The trial enrolled 60 patients at multiple clinical sites in the United States. The study involved once-daily oral administration of either ACP-103 or a placebo for a 28-day period to patients who also received their stable dopamine replacement therapy.
The design of the study permitted escalation of the initial 20 mg dose of ACP-103 to 40 mg and then to 60 mg at two scheduled intervals during the study.
Fewer patients on ACP-103 were escalated to higher doses as compared to placebo-treated patients, and the mean total dose of ACP-103 was significantly less than the mean total dose of a placebo.
San Diego-based Acadia is a biopharmaceutical company developing treatments for central nervous system disorders.
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