Clinical trial NCT01174004: A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
Official title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 199
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: The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).


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
* Subjects that are on anti-Parkinson's medication must be on a stable dose 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
* Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

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, 15, 29 and 43)
Secondary outcomes:
measure: Motor Symptoms Change From Baseline (Negative = Improvement)
timeFrame: Study Days 1 and 43
Other outcomes:
Locations:
city: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Carson
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Habra
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Reseda
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Ventura
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Elk Grove Village
country: United States
state: Illinois
city: Glenview
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Scarborough
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Novi
country: United States
state: Michigan
city: Roseville
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Flowood
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Toms River
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Commack
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Greensburg
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Brentwood
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Alexandria
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Ottawa
country: Canada
state: Ontario
Study officials:
References:
citation: Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1.