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

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ClinicalTrials.gov Identifier: NCT00477672
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : March 26, 2014
Last Update Posted : May 17, 2017
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 (ACP-103)
Drug: Placebo

  Participant Flow

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 10 mg Pimavanserin tartrate (ACP-103) 10 mg, 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 10 mg   Pimavanserin 40 mg
STARTED   98   101   99 
COMPLETED   91   85   83 
NOT COMPLETED   7   16   16 
Adverse Event                3                5                6 
Death                0                1                0 
Disease progression                0                1                0 
Physician Decision                1                0                0 
Protocol noncompliance                0                2                0 
Consent withdrawn                2                5                10 
Discretion of Sponsor                1                2                0 



  Baseline Characteristics

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.
Safety Analysis Set

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 10 mg Pimavanserin tartrate (ACP-103) 10 mg, 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 10 mg   Pimavanserin 40 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   99   98   295 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      27  27.6%      30  30.3%      23  23.5%      80  27.1% 
>=65 years      71  72.4%      69  69.7%      75  76.5%      215  72.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.6  (9.67)   69.0  (8.61)   69.4  (7.84)   69.3  (8.71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      47  48.0%      36  36.4%      24  24.5%      107  36.3% 
Male      51  52.0%      63  63.6%      74  75.5%      188  63.7% 
Region of Enrollment 
[Units: Participants]
       
United States   44   45   45   134 
India   10   10   10   30 
Europe   44   44   43   131 


  Outcome Measures

1.  Primary:   Antipsychotic Efficacy   [ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ]

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 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.

Time Frame Each study visit (i.e. Days 1, 8, 15, 29 and 42)  

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.

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 10 mg Pimavanserin tartrate (ACP-103) 10 mg, 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 10 mg   Pimavanserin 40 mg 
Participants Analyzed   95   96   91 
Antipsychotic Efficacy 
[Units: Score on the SAPS H+D scale]
Least Squares Mean (95% Confidence Interval)
     
Change from Baseline   -5.9 
 (-7.3 to -4.5) 
 -5.8 
 (-7.2 to -4.3) 
 -6.7 
 (-8.1 to -5.2) 
Difference of Least Squares Mean versus Placebo   NA [1]   0.1 
 (-1.7 to 2.0) 
 -0.8 
 (-2.7 to 1.1) 
[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: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ]

Measure Type Secondary
Measure Title Motor Symptoms Change From Baseline (Negative = Improvement)
Measure Description

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.

Time Frame Each study visit (i.e. Days 1, 8, 15, 29 and 42)  

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 "Per Protocol" population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received.

Reporting Groups
  Description
Placebo Placebo tablet, once daily by mouth, 6 weeks
Pimavanserin 10 mg Pimavanserin tartrate (ACP-103) 10 mg, 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 10 mg   Pimavanserin 40 mg 
Participants Analyzed   90   88   85 
Motor Symptoms Change From Baseline (Negative = Improvement) 
[Units: Score on UPDRS-II+III]
Least Squares Mean (95% Confidence Interval)
     
Change from Baseline   -2.94 
 (-5.08 to -0.80) 
 -1.41 
 (-3.58 to 0.76) 
 -3.13 
 (-5.34 to -0.91) 
Difference of Least Square Mean versus Placebo   NA [1]   1.53 
 (-1.24 to 4.31) 
 -0.19 
 (-2.99 to 2.62) 
[1] Calculation is a comparison of active arm versus placebo.

No statistical analysis provided for Motor Symptoms Change From Baseline (Negative = Improvement)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00477672     History of Changes
Other Study ID Numbers: ACP-103-012
First Submitted: May 22, 2007
First Posted: May 24, 2007
Results First Submitted: February 6, 2014
Results First Posted: March 26, 2014
Last Update Posted: May 17, 2017