Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00550238
First received: October 26, 2007
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Duration of the treatment period ]

Estimated Enrollment: 500
Study Start Date: July 2007
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Drug: Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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

ClinicalTrials.gov processed this record on May 24, 2017