Clinical trial NCT00477672: A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease Psychosis
Keywords: Parkinson's disease, psychotic disorders
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 298
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 PD 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: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Carson
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Irvine
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Fairfield
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Springfield
country: United States
state: Illinois
city: Scarborough
country: United States
state: Maine
city: Worcester
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Toms River
country: United States
state: New Jersey
city: Kingston
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Warwick
country: United States
state: Rhode Island
city: Brentwood
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Pleven
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Clermont ferrand
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Pessac
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Bangalore
country: India
city: Hyderabad
country: India
city: Karnataka
country: India
city: Mangalore
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: New Dalhi
country: India
city: Pune
country: India
city: Pune
country: India
city: Tamil Nadu
country: India
city: Tamil Nadu
country: India
city: Visakhapatnam
country: India
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Barnsley
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Brighton
country: United Kingdom
city: Dorset
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: North Shields
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
References: