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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00550238
Recruitment Status : Active, not recruiting
First Posted : October 29, 2007
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Psychosis Drug: Pimavanserin tartrate (ACP-103) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Drug: Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Primary Outcome Measures :
  1. Safety [ Time Frame: Duration of the treatment period ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Duration of the treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00550238

  Hide Study Locations
United States, Arizona
Gilbert, Arizona, United States, 85234
Phoenix, Arizona, United States, 85013
United States, California
Berkeley, California, United States, 94705
Carson, California, United States, 90746
Fountain Valley, California, United States, 92708
Fresno, California, United States, 93720
Irvine, California, United States, 92697
La Habra, California, United States, 90631
La Jolla, California, United States, 92037
Laguna Hills, California, United States, 92653
Loma Linda, California, United States, 92354
Oxnard, California, United States, 93030
Reseda, California, United States, 91335
Sunnyvale, California, United States, 94085
Ventura, California, United States, 93003
United States, Colorado
Englewood, Colorado, United States, 80113
United States, Connecticut
Danbury, Connecticut, United States, 06810
Fairfield, Connecticut, United States, 06824
Farmington, Connecticut, United States, 06030
United States, Florida
Boca Raton, Florida, United States, 33486
Bradenton, Florida, United States, 34205
Deerfield Beach, Florida, United States, 33064
Gainesville, Florida, United States, 32610
Jacksonville, Florida, United States, 32209
Miami, Florida, United States, 33136
Naples, Florida, United States, 34102
Orlando, Florida, United States, 32806
Ormond Beach, Florida, United States, 32174
Panama City, Florida, United States, 32405
Pompano Beach, Florida, United States, 33060
Port Charlotte, Florida, United States, 33952
Port Charlotte, Florida, United States, 33980
Saint Petersburg, Florida, United States, 33701
Sarasota, Florida, United States, 34233
Tampa, Florida, United States, 33606
United States, Georgia
Augusta, Georgia, United States, 30912
Decatur, Georgia, United States, 30033
United States, Illinois
Glenview, Illinois, United States, 60026
Springfield, Illinois, United States, 62794
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maine
Scarborough, Maine, United States, 04074
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Worcester, Massachusetts, United States, 01655
United States, Michigan
Clinton, Michigan, United States, 48037
Detroit, Michigan, United States, 48201
East Lansing, Michigan, United States, 48824
Traverse City, Michigan, United States, 49684
United States, Missouri
Columbia, Missouri, United States, 65201
Saint Louis, Missouri, United States, 63110
United States, Montana
Missoula, Montana, United States, 59802
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Albany, New York, United States, 12208
Commack, New York, United States, 11725
Kingston, New York, United States, 12401
Rochester, New York, United States, 14618
United States, North Carolina
Asheville, North Carolina, United States, 28806
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27705
New Bern, North Carolina, United States, 28562
Salisbury, North Carolina, United States, 28144
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Greensburg, Pennsylvania, United States, 15601
Philadelphia, Pennsylvania, United States, 19131
Philadelphia, Pennsylvania, United States, 19141
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Brentwood, Tennessee, United States, 37027
United States, Texas
Houston, Texas, United States, 77030
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Alexandria, Virginia, United States, 22311
Roanoke, Virginia, United States, 24018
Virginia Beach, Virginia, United States, 23456
United States, Washington
Kirkland, Washington, United States, 98034
Spokane, Washington, United States, 99204
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53233
Innsbruck, Austria, 6020
Vienna, Austria, 1090
Roeselare, Belgium, 8800
Clermont Ferrand, France, 63003
Marseille, France, 13005
Nantes Cedex, France, 44093
Pessac, France, 33600
Strasbourg, France, 67091
Bangalore, India, 560 034
Chennai, India, 600 006
Hyderabad, India, 500003
Madurai, India, 625 020
Mangalore, India, 575 001
Mangalore, India, 575 002
Mumbai, India, 400 016
Mumbai, India, 400 036
Pune, India, 411 004
Pune, India, 411 030
Vishakhapatnam, India, 530 002
Chieti Scalo (CH), Italy, 66013
Grosseto, Italy, 58100
Rome, Italy, 00163
Rome, Italy, 00185
Bydogszcz, Poland, 85796
Katowice, Poland, 40-752
Lublin, Poland, 20-090
Coimbra, Portugal, 3000-548
Lisboa, Portugal, 1649-028
Porto, Portugal, 4099-001
Russian Federation
Kazan, Russian Federation, 420061
Kirov, Russian Federation, 610014
Moscow, Russian Federation, 125284
Pyatigorsk, Russian Federation, 357538
Samara, Russian Federation, 443095
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 194044
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Stockholm, Sweden, SE-112 45
Kharkov, Ukraine, 61068
Kiev, Ukraine, 04080
Kiev, Ukraine, 04114
Lviv, Ukraine, 79010
Vinnitsia, Ukraine, 21005
United Kingdom
Barnsley, United Kingdom, S75 2EP
Blackburn, United Kingdom, BB2 3HH
London, United Kingdom, NW3 2PF
Newcastle, United Kingdom, NE4 6BE
Tyne and Wear, United Kingdom, NE29 8NH
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT00550238     History of Changes
Other Study ID Numbers: ACP-103-015
First Posted: October 29, 2007    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ACADIA Pharmaceuticals Inc.:
Parkinson's Disease Psychosis

Additional relevant MeSH terms:
Parkinson Disease
Psychotic Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action