Efficacy results of pimavanserin from a multi-center, open-label extension study in Parkinson's disease psychosis patients

• DOI: 10.1016/j.parkreldis.2021.04.012
• Publication Date: 2021-04-28T10:42:59Z
• Authors: Stuart H. Isaacson; Clive G. Ballard; David L. Kreitzman; Bruce Coate; James C. Norton; Hubert H. Fernandez; Tihomir V. Ilic; Jean-Philippe Azulay; Joaquim J. Ferreira; Victor Abler; Srdjan Stankovic
• Keywords: Clinical Global Impression; Tolerability

IntroductionPimavanserin, a selective 5-HT2A inverse agonist/antagonist, was approved for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). We present durability of response pimavanserin in patients PDP an additional 4 weeks treatment.MethodsThis open-label extension (OLE) study previously completing one three double-blind, placebo-controlled (Core) studies. All received 34 mg once daily. Efficacy assessments included the Scale Assessment Positive Symptoms (SAPS) PD H + D scales, Clinical Global Impression (CGI) Improvement Severity scales Caregiver Burden (CBS), through OLE. Safety were conducted at each visit.ResultsOf 459 patients, 424 (92.4%) had Week efficacy assessment. At (10 total treatment), SAPS-PD mean (standard deviation) change from OLE baseline −1.8 (5.5) SAPS-H −2.1 (6.2) mg. Patients receiving placebo during Core studies greater improvements (SAPS-PD -2.9 [5.6]; −3.5 [6.3]) For participants treated 8.5 or 17 studies, further improvement observed The Study score similar among prior placebo-treated (−7.1 vs. −7.0). CGI-I rate (score 1 2) 51.4%. Adverse events reported by 215 (46.8%) first most common AEs fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), peripheral edema (2.2%)ConclusionsPatients on blinded core subsequent week improved after OL treatment. These results over 400 14 countries support treating PDP.