NCT03623321

Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

A 52-Week Open-label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 595 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

Conditions

• Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Interventions

Type	Name	Description
DRUG	Pimavanserin	• Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.

Timeline

• Start date: 2018-07-17
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2018-08-09
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

88 sites across 12 countries: United States, Bulgaria, Colombia, Czechia, Georgia, Mexico, Poland, Romania, Russia, Serbia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study