A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
First received: October 26, 2007
Last updated: May 17, 2016
Last verified: May 2016
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Condition Intervention Phase
Parkinson's Disease Psychosis
Drug: pimavanserin tartrate (ACP-103)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2007
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pimavanserin tartrate (ACP-103)
    tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has completed the treatment period of a previous blinded study of pimavanserin
  • The subject is willing and able to provide consent
  • Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

  • Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
  • Subject is judged by the Investigator to be inappropriate for the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550238

  Show 125 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00550238     History of Changes
Other Study ID Numbers: ACP-103-015 
Study First Received: October 26, 2007
Last Updated: May 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:
Parkinson's Disease Psychosis

Additional relevant MeSH terms:
Mental Disorders
Parkinson Disease
Psychotic Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on May 30, 2016