Clinical trial NCT00658567: A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 123
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Antipsychotic Efficacy
timeFrame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Secondary outcomes:
measure: Motor Symptoms Change From Baseline (Negative = Improvement)
timeFrame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Other outcomes:
Locations:
city: La Habra
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Reseda
country: United States
state: California
city: Ventura
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Deerfield Beach
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Clinton
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: East Lansing
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Albany
country: United States
state: New York
city: Commack
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Innsbruck
country: Austria
city: Brussels
country: Belgium
city: Ottignies
country: Belgium
city: Roeselare
country: Belgium
city: Chieti Scalo
country: Italy
city: Grossetto
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Bydgoszcz
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Belgrade
country: Serbia
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: San Sebastian
country: Spain
city: Santiago De Compostela
country: Spain
city: Jonkoping
country: Sweden
city: Linkoping
country: Sweden
city: Stockholm
country: Sweden
Study officials:
References: