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;   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 (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
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Consent withdrawn                 2                 5                 10  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
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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  
Number of Participants  
[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


  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.


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.  


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


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
Health Authority: United States: Food and Drug Administration