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

Last updated: April 18, 2017
Sponsor: ACADIA Pharmaceuticals Inc.
Overall Status: Completed

Phase

3

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT00477672
ACP-103-012
  • Ages > 40
  • All Genders

Study 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

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 duringthe 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 toStudy Day 1 (Baseline) and during the trial

  • Subject that has received stereotaxic surgery for subthalamic nucleus deep brainstimulation must be at least 6 months post surgery and the stimulator settings musthave been stable for at least 1 month prior to Study Day 1 (Baseline) and must remainstable 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

Exclusion Criteria:

  • Subject has a history of significant psychotic disorders prior to or concomitantlywith the diagnosis of Parkinson's disease including, but not limited to, schizophreniaor bipolar disorder

  • Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy andthalamotomy) 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 participationare met. These evaluations will include specific measures of psychosis severity, delirium,dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from thestudy based on these assessments (and specifically if it is determined that their baselinehealth and psychiatric condition do not meet all protocol-specified entry criteria).

Study Design

Total Participants: 298
Study Start date:
June 01, 2007
Estimated Completion Date:
July 31, 2009

Connect with a study center

  • Pleven, 5800
    Bulgaria

    Site Not Available

  • Rousse, 7003
    Bulgaria

    Site Not Available

  • Sofia, 1113
    Bulgaria

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  • Varna, 9010
    Bulgaria

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  • Clermont ferrand, 63003
    France

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  • Marseille, 13385
    France

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  • Nantes, 44093
    France

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  • Pessac, 33604
    France

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  • Strasbourg, 67091
    France

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  • Toulouse, 35059
    France

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  • Bangalore, 560034
    India

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  • Hyderabad, 500003
    India

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  • Karnataka, 575001
    India

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  • Mangalore, 575002
    India

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  • Mumbai, 400016
    India

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  • New Dalhi, 110060
    India

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  • Pune, 411004
    India

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  • Tamil Nadu, 625020
    India

    Site Not Available

  • Visakhapatnam, 530001
    India

    Site Not Available

  • Kazan, 420061
    Russian Federation

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  • Kirov, 610014
    Russian Federation

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  • Moscow, 125284
    Russian Federation

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  • Samara, 443095
    Russian Federation

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  • Smolensk, 214018
    Russian Federation

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  • St. Petersburg, 194044
    Russian Federation

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  • Kharkiv, 61068
    Ukraine

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  • Kiev, 04080
    Ukraine

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  • Lugansk, 91045
    Ukraine

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  • Lviv, 79010
    Ukraine

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  • Vinnytsia, 21005
    Ukraine

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  • Barnsley, S75 2EP
    United Kingdom

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  • Blackburn, BB3 2HH
    United Kingdom

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  • Brighton, BN2 5BE
    United Kingdom

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  • Dorset, BH23 2JX
    United Kingdom

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  • London, NW3 2PF
    United Kingdom

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  • Newcastle upon Tyne, NE4 6BE
    United Kingdom

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  • North Shields, NE29 8NH
    United Kingdom

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  • Salford, M6 8HD
    United Kingdom

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  • Gilbert, Arizona 85234
    United States

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  • Phoenix, Arizona 85013
    United States

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  • Berkeley, California 94705
    United States

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  • Carson, California 90746
    United States

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  • Fountain Valley, California 92708
    United States

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  • Irvine, California 92697
    United States

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  • Sunnyvale, California 94805
    United States

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  • Danbury, Connecticut 06810
    United States

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  • Fairfield, Connecticut 06824
    United States

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  • Boca Raton, Florida 33486
    United States

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  • Gainesville, Florida 32610
    United States

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    Gainsville, Florida 32610
    United States

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  • Jacksonville, Florida 32209
    United States

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  • Miami, Florida 33136
    United States

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  • Pompano Beach, Florida 33060
    United States

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  • Port Charlotte, Florida 33952
    United States

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  • Saint Petersburg, Florida 33701
    United States

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  • Sarasota, Florida 34239
    United States

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  • Tampa, Florida 33606
    United States

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  • Augusta, Georgia 30912
    United States

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  • Springfield, Illinois 62794
    United States

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  • Scarborough, Maine 04074
    United States

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  • Worcester, Massachusetts 01655
    United States

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  • Southfield, Michigan 48034
    United States

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  • Traverse City, Michigan 49684
    United States

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  • Toms River, New Jersey 08755
    United States

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  • Kingston, New York 12401
    United States

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  • Rochester, New York 14618
    United States

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  • Asheville, North Carolina 28806
    United States

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  • Salisbury, North Carolina 28144
    United States

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  • Columbus, Ohio 43210
    United States

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  • Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Brentwood, Tennessee 37027
    United States

    Site Not Available

  • San Antonio, Texas 78258
    United States

    Site Not Available

  • Richmond, Virginia 23229
    United States

    Site Not Available

  • Kirkland, Washington 98034
    United States

    Site Not Available

  • Spokane, Washington 99204
    United States

    Site Not Available

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