An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients

An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients

This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease Psychosis
• Intervention / Treatment: Drug: pimavanserin tartrate (ACP-103)

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Danbury, Connecticut, United States, 06810

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria-

• Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
• Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
• Patient is willing and able to provide consent

Exclusion Criteria-

• Female patient of childbearing potential
• Patient has a clinically significant concurrent medical illness
• Patient is judged by the treating physician to be inappropriate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pimavanserin tartrate (ACP-103); Tablets taken once daily by mouth at 20, 40, or 60 mg doses	Drug: pimavanserin tartrate (ACP-103); Tablets taken once daily by mouth at 20, 40, or 60 mg doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)	Number (%) of patients with drug-related treatment-emergent AEs	From first to last study drug dose plus 30 days

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2004
• Primary Completion (Actual): May 2, 2013
• Study Completion (Actual): May 2, 2013

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Pimavanserin
• Other Study ID Numbers: ACP-103-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No