Trial record 1 of 1 for:    acp-103-015
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A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00550238
First received: October 26, 2007
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Parkinson's Disease Psychosis
Drug: pimavanserin tartrate (ACP-103)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pimavanserin tartrate (ACP-103)
    tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550238

  Hide Study Locations
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
Sarasota, Florida, United States, 34233
St. Petersburg, Florida, United States, 33701
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
Worchester, Massachusetts, United States, 01655
United States, Michigan
Clinton Twp, 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
St. 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, 19141
Philadelphia, Pennsylvania, United States, 19131
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
Austria
Innsbruck, Austria, 6020
Vienna, Austria, 1090
Belgium
Roeselare, Belgium, 8800
France
Clermont Ferrand, France, 63003
Marseille, France, 13005
Nantes Cedex, France, 44093
Pessac, France, 33600
Strasbourg, France, 67091
India
Bangalore, India, 560 034
Chennai, India, 600 006
Hyderabad, India, 500003
Madurai, India, 625 020
Mangalore, India, 575 002
Mangalore, India, 575 001
Mumbai, India, 400 036
Mumbai, India, 400 016
Pune, India, 411 030
Pune, India, 411 004
Vishakhapatnam, India, 530 002
Italy
Chieti Scalo (CH), Italy, 66013
Grosseto, Italy, 58100
Rome, Italy, 00163
Rome, Italy, 00185
Poland
Bydogszcz, Poland, 85796
Katowice, Poland, 40-752
Lublin, Poland, 20-090
Portugal
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
Serbia
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Sweden
Stockholm, Sweden, SE-112 45
Ukraine
Kharkov, Ukraine, 61068
Kiev, Ukraine, 04114
Kiev, Ukraine, 04080
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.
  More Information

No publications provided

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00550238     History of Changes
Other Study ID Numbers: ACP-103-015
Study First Received: October 26, 2007
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Parkinson Disease
Mental Disorders
Psychotic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia and Disorders with Psychotic Features
Pimavanserin
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014