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

NCT00550238 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ACP-103-015
• Study Type: interventional
• Target: 459
• Locations: 13 countries
• Sites: 133

Brief Summary

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

Conditions

Parkinson's Disease Psychosis

Keywords

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)

  Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)

  From first to last study drug dose plus 30 days

Study Arms (1)

Pimavanserin tartrate (ACP-103)

EXPERIMENTAL

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)

Interventions

Pimavanserin tartrate (ACP-103) DRUG

Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Pimavanserin tartrate (ACP-103)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (135)

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Gilbert, Arizona, 85234, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 84724, 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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Fresno, California, 93720, United States

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Irvine, California, 92697, United States

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La Habra, California, 90631, United States

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La Jolla, California, 92037, United States

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Laguna Hills, California, 92653, United States

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Loma Linda, California, 92354, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Reseda, California, 91335, United States

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Sunnyvale, California, 94085, United States

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Ventura, California, 93003, United States

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Englewood, Colorado, 80113, United States

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Danbury, Connecticut, 06810, United States

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Fairfield, Connecticut, 06824, United States

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Farmington, Connecticut, 06030, United States

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Boca Raton, Florida, 33486, United States

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Bradenton, Florida, 34205, United States

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Deerfield Beach, Florida, 33064, United States

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Gainesville, 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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Naples, Florida, 34102, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Panama City, Florida, 32405, United States

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Pompano Beach, Florida, 33060, United States

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Port Charlotte, Florida, 33980, United States

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Sarasota, Florida, 34233, United States

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St. Petersburg, Florida, 33701, United States

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Tampa, Florida, 33606, United States

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Augusta, Georgia, 30912, United States

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Decatur, Georgia, 30033, United States

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Glenview, Illinois, 60026, United States

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Springfield, Illinois, 62794, United States

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Kansas City, Kansas, 66160, United States

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Louisville, Kentucky, 40202, United States

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Scarborough, Maine, 04074, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02215, United States

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Worcester, Massachusetts, 01655, United States

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Clinton Township, Michigan, 48037, United States

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Detroit, Michigan, 48201, United States

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East Lansing, Michigan, 48824, United States

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Roseville, Michigan, 48066, United States

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Traverse City, Michigan, 49684, United States

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West Bloomfield, Michigan, 48334, United States

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Columbia, Missouri, 65201, United States

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St Louis, Missouri, 63110, United States

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Missoula, Montana, 59802, United States

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Toms River, New Jersey, 08755, United States

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Albany, New York, 12208, United States

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Commack, New York, 11725, 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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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27705, United States

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New Bern, North Carolina, 28562, United States

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Salisbury, North Carolina, 28144, United States

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Cincinnati, Ohio, 45210, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Toledo, Ohio, 43614, United States

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Greensburg, Pennsylvania, 15601, United States

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Philadelphia, Pennsylvania, 19131, United States

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Providence, Rhode Island, 02906, United States

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Brentwood, Tennessee, 37027, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84108, United States

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Burlington, Vermont, 05401, United States

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Alexandria, Virginia, 22311, United States

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Richmond, Virginia, 23229, United States

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Roanoke, Virginia, 24018, United States

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Virginia Beach, Virginia, 23456, United States

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Kirkland, Washington, 98034, United States

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Spokane, Washington, 99204, United States

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Milwaukee, Wisconsin, 53233, United States

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Roeselare, 8800, Belgium

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1G 4G3, Canada

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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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Bangalore, 560 034, India

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Chennai, 600 006, India

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Hyderabad, 500003, India

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Madurai, 625 020, India

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Mangalore, 575 001, India

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Mangalore, 575 002, India

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Mumbai, 400 016, India

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Mumbai, 400 026, India

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Pune, 411 004, India

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Pune, 411 030, India

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Visakhapatnam, 530 002, India

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Chieti, 66013, Italy

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Grosseto, 58100, Italy

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Rome, 00163, Italy

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Rome, 00185, Italy

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Bydgoszcz, 85796, Poland

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Katowice, 40-752, Poland

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Lublin, 20-090, Poland

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Coimbra, 3000-548, Portugal

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Lisbon, 1649-028, Portugal

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Porto, 4099-001, Portugal

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Kazan', 420061, Russia

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Kirov, 610014, Russia

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Moscow, 125284, Russia

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Pyatigorsk, 357538, Russia

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Saint Petersburg, 194044, Russia

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Samara, 443095, Russia

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Smolensk, 214018, Russia

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Belgrade, 11000, Serbia

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Novi Sad, 21000, Serbia

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Stockholm, SE-112 45, Sweden

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Kharkiv, 61068, Ukraine

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Kiev, 04080, Ukraine

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Kiev, 04114, Ukraine

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Luhansk, 91045, Ukraine

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Lviv, 79010, Ukraine

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Vinnitsia, 21005, Ukraine

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Barnsley, S75 2EP, United Kingdom

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Blackburn, BB2 3HH, United Kingdom

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London, NW3 20G, United Kingdom

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Newcastle, NE4 6BE, United Kingdom

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North Shields, NE21 8NH, United Kingdom

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Related Publications (2)

• 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.

  PMID: 28493654 BACKGROUND

• 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.

  PMID: 26239690 DERIVED

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: ACADIA Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261-2897

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 29, 2007
• Study Start: July 1, 2007
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 24, 2019
• Results First Posted: June 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); GB (5); RU (7); BE (1); PL (3); AU (2); IN (11); US (83); IT (4); UA (6); FR (5); CA (2); PT (3)