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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: May 17, 2016
Last verified: May 2016

October 26, 2007
May 17, 2016
July 2007
December 2017   (final data collection date for primary outcome measure)
Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00550238 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease Psychosis
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
Not Provided
Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
Not Provided
December 2017   (final data collection date for primary outcome measure)

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
Both
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   France,   India,   Italy,   Poland,   Portugal,   Russian Federation,   Serbia,   Sweden,   Ukraine,   United Kingdom
 
NCT00550238
ACP-103-015
Not Provided
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Not Provided
Not Provided
ACADIA Pharmaceuticals Inc.
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP