Blinded SAPS-PD Assessment After 10 Weeks of Pimavanserin Treatment for Parkinson's Disease Psychosis.

Stuart H Isaacson,Srdjan Stankovic,James Norton,Bruce Coate

doi:10.3233/jpd-202047

Abstract

Background:Parkinson’s disease psychosis (PDP) is a common nonmotor symptom that affects up to 60% of patients. Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, is approved for treating hallucinations and delusions associated with PDP.Objective:Evaluate the efficacy and tolerability of pimavanserin in an open-label extension (OLE) study.Methods:Patients completing a pivotal 6-week placebo-controlled trial (Core Study) could enroll in the OLE. All patients pimavanserin 34 mg once daily, blinded to previous treatment allocation. Prespecified blinded assessments at Week 4 were the Scale for the Assessment of Positive Symptoms (SAPS) PD version and SAPS H + D scales, Caregiver Burden Scale (CBS), and Clinical Global Impression (CGI) Improvement and Severity scales.Results:Of 171 who entered the OLE, 148 (87%) completed Week 4. Among patients who received placebo in the Core Study, mean (SD) change from OLE baseline to OLE Week 4 for the SAPS-PD was – 3.4 (6.3); p < 0.0001. Mean change from Core Study baseline to OLE Week 4 for SAPS-PD was similar among prior pimavanserin- and placebo-treated patients (–6.9 vs. –6.3). Improvement was similar with CGI-I, CGI-S, CBS, and SAPS-H + D in patients previously treated with placebo. Adverse events occurred in 92 (53.8%) patients during the 4-week OLE.Conclusion:Improvements at OLE Week 4 from pretreatment baseline were similar with placebo and pimavanserin in the Core Study. The beneficial effects observed with pimavanserin in the 6-week Core Study were maintained for 4 weeks in the blinded OLE, supporting the durability of response with pimavanserin 34 mg for PDP over 10 weeks.

Highlights

Hallucinations and delusions are common neuropsychiatric symptoms in patients with Parkinson’s disease (PD), developing in over 50% of patients over the course of their disease with progression over time [1,2,3]
For participants who had received pimavanserin during the Core study, durability of improvement on Scale for the Assessment of Positive Symptoms (SAPS)-PD was demonstrated after 10 weeks total of pimavanserin treatment without additional safety concerns
Participants entering the open-label extension (OLE) who had been randomized to the placebo arm in the Core study had similar improvement in the SAPS-PD after 4 weeks of open-label pimavanserin treatment, beginning after 2 weeks

Summary

Introduction

Hallucinations and delusions are common neuropsychiatric symptoms in patients with Parkinson’s disease (PD), developing in over 50% of patients over the course of their disease with progression over time [1,2,3]. S.H. Isaacson et al / Pimavanserin for Parkinson’s Disease Psychosis. Parkinson’s disease psychosis (PDP) is a common nonmotor symptom that affects up to 60% of patients. Methods: Patients completing a pivotal 6-week placebo-controlled trial (Core Study) could enroll in the OLE. Among patients who received placebo in the Core Study, mean (SD) change from OLE baseline to OLE Week 4 for the SAPS-PD was –3.4 (6.3); p < 0.0001. Mean change from Core Study baseline to OLE Week 4 for SAPS-PD was similar among prior pimavanserin- and placebo-treated patients (–6.9 vs –6.3). Improvement was similar with CGI-I, CGI-S, CBS, and SAPS-H + D in patients previously treated with placebo. Conclusion: Improvements at OLE Week 4 from pretreatment baseline were similar with placebo and pimavanserin in the Core Study. The beneficial effects observed with pimavanserin in the 6-week Core Study were maintained for 4 weeks in the blinded OLE, supporting the durability of response with pimavanserin 34 mg for PDP over 10 weeks

Objectives

Results

Conclusion