Abstract | BACKGROUND: 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)
|