Clinical trial NCT00550238: A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official title: A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability 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 Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-29
Enrollment: 459
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Detailed description: This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

Eligibility criteria: Inclusion Criteria:

* Subject has completed the treatment period of a previous blinded study of pimavanserin
* 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 current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
* Subject is judged by the Investigator to be inappropriate for the study

Primary outcomes:
measure: Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
timeFrame: From first to last study drug dose plus 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
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: Fresno
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: Laguna Hills
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: Englewood
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Fairfield
country: United States
state: Connecticut
city: Farmington
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
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city: Miami
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city: Naples
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city: Orlando
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city: Ormond Beach
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city: Panama City
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city: Pompano Beach
country: United States
state: Florida
city: Port Charlotte
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city: Saint Petersburg
country: United States
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city: Sarasota
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state: Florida
city: Tampa
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city: Decatur
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state: Massachusetts
city: Clinton Township
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city: Detroit
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city: East Lansing
country: United States
state: Michigan
city: Roseville
country: United States
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city: West Bloomfield
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state: Missouri
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city: Durham
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city: New Bern
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city: Cincinnati
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Brentwood
country: United States
state: Tennessee
city: Houston
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state: Texas
city: Salt Lake City
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state: Utah
city: Burlington
country: United States
state: Vermont
city: Alexandria
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
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city: Milwaukee
country: United States
state: Wisconsin
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Roeselare
country: Belgium
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Clermont Ferrand
country: France
city: Marseille
country: France
city: Nantes Cedex
country: France
city: Pessac
country: France
city: Strasbourg
country: France
city: Bangalore
country: India
city: Chennai
country: India
city: Hyderabad
country: India
city: Madurai
country: India
city: Mangalore
country: India
city: Mangalore
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Pune
country: India
city: Pune
country: India
city: Visakhapatnam
country: India
city: Chieti
country: Italy
city: Grosseto
country: Italy
city: Rome
country: Italy
city: Rome
country: Italy
city: Bydgoszcz
country: Poland
city: Katowice
country: Poland
city: Lublin
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Moscow
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Stockholm
country: Sweden
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnitsia
country: Ukraine
city: Barnsley
country: United Kingdom
city: Blackburn
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle
country: United Kingdom
city: North Shields
country: United Kingdom
Study officials:
References:
citation: Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119.
citation: Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.