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A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
This study is currently recruiting participants.
Study NCT00658567   Information provided by ACADIA Pharmaceuticals Inc.
First Received: April 10, 2008   Last Updated: July 16, 2009   History of Changes

April 10, 2008
July 16, 2009
March 2008
December 2009   (final data collection date for primary outcome measure)
Antipsychotic efficacy will be assessed using the scale for the assessment of Positive Symptoms (SAPS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658567 on ClinicalTrials.gov Archive Site
 
 
 
A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
 

This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Parkinson's Disease Psychosis
Drug: Pimavanserin tartrate (ACP-103)
  • Experimental: pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
  • Placebo Comparator: Placebo tablet, once daily by mouth, 6 weeks
  • Experimental: pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
 
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
  • Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
  • Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
  • Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
  • Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
  • 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 a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
  • Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
  • Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, mematologic or other medical disorder
  • Subject has had a myocardial infarction in last six months
  • Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Both
40 Years and older
No
Contact: Kimberly Wilson ACP-103clintrials@acadia-pharm.com
United States,   Austria,   Belgium,   Italy,   Poland,   Portugal,   Serbia,   Spain,   Sweden
 
NCT00658567
Kimberly Wilson, ACADIA Pharmaceuticals Inc.
ACP-103-014
ACADIA Pharmaceuticals Inc.
 
 
ACADIA Pharmaceuticals Inc.
July 2009

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