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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00477672
First received: May 22, 2007
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: February 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease Psychosis
Interventions: Drug: Pimavanserin tartrate (ACP-103)
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
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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Consent withdrawn                2                5                10 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
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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.
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]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   27   30   23   80 
>=65 years   71   69   75   215 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.6  (9.67)   69.0  (8.61)   69.4  (7.84)   69.3  (8.71) 
Gender 
[Units: Participants]
       
Female   47   36   24   107 
Male   51   63   74   188 
Region of Enrollment 
[Units: Participants]
       
United States   44   45   45   134 
India   10   10   10   30 
Europe   44   44   43   131 


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

2.  Secondary:   Motor Symptoms Change From Baseline (Negative = Improvement)   [ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ]


  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



Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00477672     History of Changes
Other Study ID Numbers: ACP-103-012
Study First Received: May 22, 2007
Results First Received: February 6, 2014
Last Updated: February 6, 2014