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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
  Show All Outcome Measures

1.  Primary:   Antipsychotic Efficacy   [ Time Frame: Each study visit (i.e. Days 1, 15, 29 and 43) ]

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


  Serious Adverse Events
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Time Frame 6 weeks
Additional 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.

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

Serious Adverse Events
    Placebo     Pimavanserin 40 mg  
Total, serious adverse events      
# participants affected / at risk     4/94 (4.26%)     11/104 (10.58%)  
Cardiac disorders      
Arrhythmia † 1    
# participants affected / at risk     1/94 (1.06%)     0/104 (0.00%)  
# events     1     0  
Atrial fibrillation † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Cardio-respiratory arrest † 1    
# participants affected / at risk     1/94 (1.06%)     0/104 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Hemorrhoids † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
General disorders      
Asthenia † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Fatigue † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Multi-organ failure † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Infections and infestations      
Urinary tract infection † 1    
# participants affected / at risk     1/94 (1.06%)     3/104 (2.88%)  
# events     1     3  
Bronchitis † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Sepsis † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Septic shock † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Injury, poisoning and procedural complications      
Fall † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Fracture † 1    
# participants affected / at risk     1/94 (1.06%)     0/104 (0.00%)  
# events     1     0  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Nervous system disorders      
Parkinson's disease † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Transient ischemic attack † 1    
# participants affected / at risk     1/94 (1.06%)     0/104 (0.00%)  
# events     1     0  
Psychiatric disorders      
Psychotic disorder † 1    
# participants affected / at risk     0/94 (0.00%)     2/104 (1.92%)  
# events     0     2  
Hallucination † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Mental status changes † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Sleep disorder † 1    
# participants affected / at risk     0/94 (0.00%)     1/104 (0.96%)  
# events     0     1  
Skin and subcutaneous tissue disorders      
Decubitus ulcer † 1    
# participants affected / at risk     1/94 (1.06%)     0/104 (0.00%)  
# events     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1




  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