This site became the new on June 19th. Learn more.
Show more Menu 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... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc. Identifier:
First received: December 16, 2008
Last updated: April 18, 2017
Last verified: April 2017
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).

Condition Intervention Phase
Parkinson's Disease Psychosis Drug: pimavanserin tartrate (ACP-103) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: For as long as pimavanserin is considered to be tolerated and beneficial to enrolled patients (up to 8 years) ]

Enrollment: 39
Study Start Date: November 2004
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT01518309

United States, Connecticut
Danbury, Connecticut, United States, 06810
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT01518309     History of Changes
Other Study ID Numbers: ACP-103-010
Study First Received: December 16, 2008
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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 processed this record on July 19, 2017