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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550238
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Psychosis Drug: Pimavanserin tartrate (ACP-103) Phase 3

Detailed Description:
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) [ Time Frame: From first to last study drug dose plus 30 days ]
    Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550238


  Show 135 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  Study Documents (Full-Text)

Documents provided by ACADIA Pharmaceuticals Inc.:
Study Protocol  [PDF] July 16, 2010
Statistical Analysis Plan  [PDF] August 5, 2014


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00550238     History of Changes
Other Study ID Numbers: ACP-103-015
First Posted: October 29, 2007    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action