Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
This is a pilot, hypothesis-generating study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
Actual Study Start Date: October 23, 2019
Estimated Primary Completion Date: November 2020
Estimated Study Completion Date: December 2020
Arms:
- Experimental: Drug - pimavanserin
- Placebo Comparator: Placebo
- Active Comparator: Quetiapine
Category | Value |
---|---|
Date last updated at source | 2019-11-15 |
Study type(s) | Interventional |
Expected enrolment | 60 |
Study start date | 2019-10-23 |
Estimated primary completion date | 2020-11-01 |