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


Tracking Information

Start Date  ICMJEJuly 2007
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)		Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00550238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)		Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official Title  ICMJEA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition  ICMJEParkinson's Disease Psychosis
Intervention  ICMJEDrug: pimavanserin tartrate (ACP-103)
tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Recruitment Information

Estimated Enrollment  ICMJE500
Completion Date 
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has completed the treatment period of Study ACP-103-012
  • 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
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Kimberly WilsonACP-103clintrials@acadia-pharm.com
Location Countries  ICMJEUnited States,   Russian Federation,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00550238
Responsible PartyKimberly Wilson, ACADIA Pharmaceuticals Inc.
Study ID Numbers  ICMJEACP-103-015
Study Sponsor  ICMJEACADIA Pharmaceuticals Inc.
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByACADIA Pharmaceuticals Inc.