Expanded Access of Pimavanserin for Patients With PD Psychosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02762591
• Date of registration: 03/05/2016
• Prospective Registration: Yes
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: Expanded Access of Pimavanserin for Patients With PD Psychosis
• Scientific title: Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis
• Date of first enrolment: May 3, 2016
• Recruitment status: Approved for marketing
• URL: https://clinicaltrials.gov/show/NCT02762591
• Study type: Expanded Access
• Phase: N/A

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient meets one of the following criteria:

1. Patient has participated in a previous study of pimavanserin for Parkinson's
disease psychosis (PDP)

2. New ("De novo") patients

2. A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year

3. Female patients must be of non-childbearing potential

4. Psychotic symptoms must have developed after Parkinson's disease diagnosis was
established

5. 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

6. The patient or Legally Authorized Representative (LAR) is willing and able to provide
consent

7. The patient or LAR is willing and able to adequately communicate in English.

Exclusion Criteria:

1. 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

2. Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's
disease that may be inconsistent with a Parkinson's diagnosis

3. 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

4. Patient has had a myocardial infarction in last six months

5. 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).



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease Psychosis

Intervention(s)

Drug: Pimavanserin tartrate

Secondary ID(s)

ACP-103-036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors