A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00658567
• Date of registration: 10/04/2008
• Prospective Registration: No
• Primary sponsor: ACADIA Pharmaceuticals Inc.
• Public title: A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
• Date of first enrolment: March 2008
• Target sample size: 123
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00658567
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Italy, Poland, Portugal, Serbia, Spain, Sweden, United States

Key inclusion & exclusion criteria

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, hematologic 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).



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 (ACP-103)

Primary Outcome(s)

Antipsychotic Efficacy [Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)]

Secondary Outcome(s)

Motor Symptoms Change From Baseline (Negative = Improvement) [Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)]

Secondary ID(s)

ACP-103-014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00658567