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

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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:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease Psychosis
Interventions Drug: pimavanserin tartrate
Drug: placebo
Enrollment 199
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description Placebo tablet, once daily by mouth, 6 weeks Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Period Title: Overall Study
Started 94 105
Completed 87 89
Not Completed 7 16
Reason Not Completed
Adverse Event             2             10
Withdrawal by Subject             2             3
At Discretion of Sponsor             2             2
Protocol Violation             0             1
Physician Decision             1             0
Arm/Group Title Placebo Pimavanserin 40 mg Total
Hide Arm/Group Description Placebo tablet, once daily by mouth, 6 weeks Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 94 104 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 104 participants 198 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  11.7%
12
  11.5%
23
  11.6%
>=65 years
83
  88.3%
92
  88.5%
175
  88.4%
[1]
Measure Description: Safety Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 104 participants 198 participants
72.7  (8.03) 72.6  (6.49) 72.7  (7.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 104 participants 198 participants
Female
38
  40.4%
34
  32.7%
72
  36.4%
Male
56
  59.6%
70
  67.3%
126
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 104 participants 198 participants
United States 92 101 193
Canada 2 3 5
1.Primary Outcome
Title Antipsychotic Efficacy
Hide Description

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)

Time Frame Each study visit (i.e. Days 1, 15, 29 and 43)
Hide Outcome Measure Data
Hide Analysis Population Description
This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description:
Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Overall Number of Participants Analyzed 90 95
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on the SAPS-PD scale
Change from Baseline
-2.73
(-4.05 to -1.42)
-5.79
(-7.09 to -4.49)
Difference of Least Squares Mean versus Placebo
NA [1] 
(NA to NA)
-3.06
(-4.91 to -1.20)
[1]
Calculation is a comparison of active arm versus placebo.
2.Secondary Outcome
Title Motor Symptoms Change From Baseline (Negative = Improvement)
Hide Description

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.

Time Frame Study Days 1 and 43
Hide Outcome Measure Data
Hide Analysis Population Description
This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description:
Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Overall Number of Participants Analyzed 90 95
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on the UPDRS-II+III
Change from Baseline
-1.69
(-3.43 to 0.05)
-1.40
(-3.10 to 0.30)
Difference of Least Squares Mean versus Placebo
NA [1] 
(NA to NA)
0.29
(-2.14 to 2.72)
[1]
Calculation is a comparison of active arm versus placebo.
Time Frame 6 weeks
Adverse Event Reporting Description From the time the informed consent was signed, adverse events were recorded in the subject's source documents and entered into the appropriate eCRF pages at the Screening visit, at visits on Study Days 1, 15, 29, 43 and Day 71 or 4 weeks after the last dose for subjects who do not continue into the open-label, extension protocol.
 
Arm/Group Title Placebo Pimavanserin 40 mg
Hide Arm/Group Description Placebo tablet, once daily by mouth, 6 weeks Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
All-Cause Mortality
Placebo Pimavanserin 40 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Pimavanserin 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/94 (4.26%)      11/104 (10.58%)    
Cardiac disorders     
Arrhythmia  1  1/94 (1.06%)  1 0/104 (0.00%)  0
Atrial fibrillation  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Cardio-respiratory arrest  1  1/94 (1.06%)  1 0/104 (0.00%)  0
Gastrointestinal disorders     
Hemorrhoids  1  0/94 (0.00%)  0 1/104 (0.96%)  1
General disorders     
Asthenia  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Fatigue  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Multi-organ failure  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Infections and infestations     
Urinary tract infection  1  1/94 (1.06%)  1 3/104 (2.88%)  3
Bronchitis  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Sepsis  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Septic shock  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Injury, poisoning and procedural complications     
Fall  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Fracture  1  1/94 (1.06%)  1 0/104 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Nervous system disorders     
Parkinson's disease  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Transient ischemic attack  1  1/94 (1.06%)  1 0/104 (0.00%)  0
Psychiatric disorders     
Psychotic disorder  1  0/94 (0.00%)  0 2/104 (1.92%)  2
Hallucination  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Mental status changes  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Sleep disorder  1  0/94 (0.00%)  0 1/104 (0.96%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/94 (1.06%)  1 0/104 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Placebo Pimavanserin 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/94 (32.98%)      41/104 (39.42%)    
Gastrointestinal disorders     
Nausea  1  6/94 (6.38%)  6 6/104 (5.77%)  7
General disorders     
Edema peripheral  1  3/94 (3.19%)  3 7/104 (6.73%)  7
Infections and infestations     
Urinary tract infection  1  11/94 (11.70%)  12 14/104 (13.46%)  16
Injury, poisoning and procedural complications     
Fall  1  8/94 (8.51%)  9 11/104 (10.58%)  14
Nervous system disorders     
Confusional state  1  3/94 (3.19%)  4 6/104 (5.77%)  6
Headache  1  5/94 (5.32%)  5 1/104 (0.96%)  1
Psychiatric disorders     
Hallucination  1  1/94 (1.06%)  1 7/104 (6.73%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roger Mills, MD
Organization: ACADIA Pharmaceuticals Inc.
Phone: 858-202-7563
EMail: rmills@acadia-pharm.com
Layout table for additonal information
Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01174004    
Other Study ID Numbers: ACP-103-020
First Submitted: July 30, 2010
First Posted: August 3, 2010
Results First Submitted: February 6, 2014
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014