CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 595 enrolled
Drug / intervention
Pimavanserindrug
Likely dose
Pimavanserin 34 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03623321
NCT03623321Phase 3Completed
CompareCT.gov

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

ACADIA Pharmaceuticals Inc.·interventional·Posted Aug 9, 2018·Updated Dec 20, 2024

In Brief

A Phase 3 clinical trial evaluating Pimavanserin for Neuropsychiatric Symptoms Related to Neurodegenerative Disease. Completed, enrolled 595 participants across 88 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropsychiatric Symptoms Related to Neurodegenerative Disease
CountriesBulgaria, Colombia, Czechia, Georgia, Mexico, Poland, Romania, Russia, Serbia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 9, 2018
Enrollment StartJul 17, 2018
Primary CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.9 years ago

Interventions

Pimavanserindrug

• 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.