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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01174004
First received: July 30, 2010
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: February 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease Psychosis
Interventions: Drug: pimavanserin tartrate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks

Participant Flow:   Overall Study
    Placebo     Pimavanserin 40 mg  
STARTED     94     105  
COMPLETED     87     89  
NOT COMPLETED     7     16  
Adverse Event                 2                 10  
Withdrawal by Subject                 2                 3  
At Discretion of Sponsor                 2                 2  
Protocol Violation                 0                 1  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Pimavanserin 40 mg     Total  
Number of Participants  
[units: participants]
  94     104     198  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     83     92     175  
Age  
[units: years]
Mean ± Standard Deviation
  72.7  ± 8.03     72.6  ± 6.49     72.7  ± 7.25  
Gender  
[units: participants]
     
Female     38     34     72  
Male     56     70     126  
Region of Enrollment  
[units: participants]
     
United States     92     101     193  
Canada     2     3     5  
[1] Safety Analysis Set



  Outcome Measures
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1.  Primary:   Antipsychotic Efficacy   [ Time Frame: Each study visit (i.e. Days 1, 15, 29 and 43) ]
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Measure Type Primary
Measure Title Antipsychotic Efficacy
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 40 mg Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks

Measured Values
    Placebo     Pimavanserin 40 mg  
Number of Participants Analyzed  
[units: participants]
  90     95  
Antipsychotic Efficacy  
[units: Score on the SAPS-PD scale]
Least Squares Mean ( 95% Confidence Interval )
   
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  
  ( NA to NA ) [1]
  -3.06  
  ( -4.91 to -1.20 )  
[1] Calculation is a comparison of active arm versus placebo.

No statistical analysis provided for Antipsychotic Efficacy



2.  Secondary:   Motor Symptoms Change From Baseline (Negative = Improvement)   [ Time Frame: Study Days 1 and 43 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roger Mills, MD
Organization: ACADIA Pharmaceuticals Inc.
phone: 858-202-7563
e-mail: rmills@acadia-pharm.com


No publications provided by ACADIA Pharmaceuticals Inc.

Publications automatically indexed to this study:

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01174004     History of Changes
Other Study ID Numbers: ACP-103-020
Study First Received: July 30, 2010
Results First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration