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

• ClinicalTrials.gov Identifier: NCT01174004
• Recruitment Status: Completed
• First Posted: August 3, 2010
• Results First Posted: March 26, 2014
• Last Update Posted: March 26, 2014
• Sponsor: ACADIA Pharmaceuticals Inc.
• Information provided by (Responsible Party): ACADIA Pharmaceuticals Inc.

Tracking Information

• First Submitted Date: July 30, 2010
• First Posted Date: August 3, 2010
• Results First Submitted Date: February 6, 2014
• Results First Posted Date: March 26, 2014
• Last Update Posted Date: March 26, 2014
• Study Start Date: July 2010
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2014)

Antipsychotic Efficacy [ Time Frame: 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)

• Original Primary Outcome Measures (submitted: July 30, 2010): Antipsychotic efficacy will be assessed using the Scale for the Assessment of Positive Symptoms (SAPS) [ Time Frame: 6 weeks ]

Current Secondary Outcome Measures (submitted: February 6, 2014)

Motor Symptoms Change From Baseline (Negative = Improvement) [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
• Official Title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson's Disease Psychosis

Intervention

• Drug: pimavanserin tartrate
  pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
  Other Name: ACP-103
• Drug: placebo
  placebo, tablet, once daily by mouth for 6 weeks

Study Arms

• Experimental: 1
  pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
  Intervention: Drug: pimavanserin tartrate
• Placebo Comparator: 2
  placebo, tablet, once daily by mouth for 6 weeks
  Intervention: Drug: placebo

• Publications *: Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1. Erratum in: Lancet. 2014 Jul 5;384(9937):28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 3, 2012): 199
• Original Estimated Enrollment (submitted: July 30, 2010): 170
• Actual Study Completion Date: November 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01174004
• Other Study ID Numbers: ACP-103-020
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ACADIA Pharmaceuticals Inc.
• Study Sponsor: ACADIA Pharmaceuticals Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ACADIA Pharmaceuticals Inc.
• Verification Date: February 2014