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

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.

• Authors: Stuart H Isaacson, Bruce Coate, James Norton, Srdjan Stankovic
• Journal: Journal of Parkinson's disease (J Parkinsons Dis) Vol. 10 Issue 4 Pg. 1389-1396 ( 2020) ISSN: 1877-718X [Electronic] Netherlands
• PMID: 32716320 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Piperidines
• Serotonin 5-HT2 Receptor Agonists
• Serotonin 5-HT2 Receptor Antagonists
• Urea
• pimavanserin

Topics

• Aged
• Aged, 80 and over
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Outcome Assessment, Health Care
• Parkinson Disease (complications, drug therapy)
• Piperidines (administration & dosage, adverse effects, pharmacology)
• Psychotic Disorders (drug therapy, etiology)
• Serotonin 5-HT2 Receptor Agonists (administration & dosage, adverse effects, pharmacology)
• Serotonin 5-HT2 Receptor Antagonists (administration & dosage, adverse effects, pharmacology)
• Urea (administration & dosage, adverse effects, analogs & derivatives, pharmacology)