A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

Phase 3

Completed

• Conditions: Parkinson's Disease Psychosis
• Interventions: Drug: pimavanserin tartrate; Drug: placebo

• Registration Number: NCT01174004
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Study First Posted: 2010-08-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-02
• Results First Submitted: 2014-02-06
• Results First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Results First Posted: 2014-03-26
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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
• Subjects that are on anti-Parkinson's medication must be on a stable dose 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
• Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pimavanserin tartrate	pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
2	placebo	placebo, tablet, once daily by mouth for 6 weeks

Primary Outcome Measures

Name	Time	Method
Antipsychotic Efficacy	Each study visit (i.e. Days 1, 15, 29 and 43)	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 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.; Analysis Method: Mixed Model Repeated Measures (MMRM)

Secondary Outcome Measures

Name	Time	Method
Motor Symptoms Change From Baseline (Negative = Improvement)	Study Days 1 and 43	Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.; Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the 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.