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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00477672
First received: May 22, 2007
Last updated: February 6, 2014
Last verified: February 2014

May 22, 2007
February 6, 2014
June 2007
June 2009   (final data collection date for primary outcome measure)
Antipsychotic Efficacy [ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ] [ Designated as safety issue: No ]

Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.

Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.

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Complete list of historical versions of study NCT00477672 on ClinicalTrials.gov Archive Site
Motor Symptoms Change From Baseline (Negative = Improvement) [ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ] [ Designated as safety issue: Yes ]

Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.

Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.

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A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease Psychosis
  • Drug: Pimavanserin tartrate (ACP-103)
    10 mg, tablet, once daily by mouth, 6 weeks
  • Drug: Pimavanserin tartrate (ACP-103)
    40 mg, tablet, once daily by mouth, 6 weeks
  • Drug: Placebo
    tablet, once daily by mouth, 6 weeks
  • Experimental: 2
    Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks
    Intervention: Drug: Pimavanserin tartrate (ACP-103)
  • Experimental: 3
    Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
    Interventions:
    • Drug: Pimavanserin tartrate (ACP-103)
    • Drug: Placebo
  • Placebo Comparator: 1
    Placebo tablet, once daily by mouth, 6 weeks
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
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June 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 PD 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, hematologic 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 information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   France,   India,   Russian Federation,   Ukraine,   United Kingdom
 
NCT00477672
ACP-103-012
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ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
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Not Provided
ACADIA Pharmaceuticals Inc.
February 2014

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