A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis - NCT00658567-12208 (Clinical Trial 215336)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy215336.aspx
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Albany |
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State:
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NY |
| Zip Code: |
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12208 |
| Conditions: |
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Parkinson's Disease Psychosis |
| Purpose: |
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This study will evaluate the safety and efficacy of two dose levels of pimavanserin
(ACP-103) compared to placebo in patients with Parkinson's disease psychosis.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- Presence of visual and/or auditory hallucinations, and/or delusions, occurring during
the four weeks prior to study screening
- Psychotic symptoms must have developed after Parkinson's disease diagnosis was
established
- Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to
Study Day 1 (Baseline) and during the trial
- Subject that has received stereotaxic surgery for subthalamic nucleus deep brain
stimulation must be at least 6 months post surgery and the stimulator settings must
have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain
stable during the trial
- The subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria:
- Subject has a history of significant psychotic disorders prior to or concomitantly
with the diagnosis of Parkinson's disease including, but not limited to,
schizophrenia or bipolar disorder
- Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and
thalamotomy) to treat Parkinson's disease
- Subject has current evidence of a serious and or unstable cardiovascular,
respiratory, gastrointestinal, renal, mematologic or other medical disorder
- Subject has had a myocardial infarction in last six months
- Subject has any surgery planned during the screening, treatment or follow-up periods
Patients will be evaluated at screening to ensure that all criteria for study
participation are met. These evaluations will include specific measures of psychosis
severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may
be excluded from the study based on these assessments (and specifically if it is
determined that their baseline health and psychiatric condition do not meet all
protocol-specified entry criteria). |
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| Study is available at: |
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Albany, NY 12208
United States
Primary Contact:
Kimberly Wilson
Email: ACP-103clintrials@acadia-pharm.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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