NCT04164758

Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
OTHER	Placebo	Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
DRUG	Quetiapine	Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-09-25
• Completion: 2020-09-25
• First posted: 2019-11-15
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study