Expanded Access of Pimavanserin for Patients With PD Psychosis
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Layout table for eligibility information
Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Patient meets one of the following criteria:
Patient has participated in a previous study of pimavanserin for Parkinson's disease psychosis (PDP)
New ("De novo") patients
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.
Patient 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
Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in last six months
Patient 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 pre-specified entry criteria).