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The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin tartrate | Drug | Pimavanserin tartrate 40 mg, tablet, taken as two 20 mg tablets, once daily by mouth |
Inclusion Criteria:
Patient meets one of the following criteria:
A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Female patients must be of non-childbearing potential
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Patient 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 patient or Legally Authorized Representative (LAR) is willing and able to provide consent
The patient or LAR is willing and able to adequately communicate in English.
Exclusion Criteria:
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 pre-specified entry criteria).
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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