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

May 29, 2019 updated by: ACADIA Pharmaceuticals Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
      • Vienna, Austria, 1090
  • Belgium
      • Roeselare, Belgium, 8800
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1G 4G3
  • France
      • Clermont Ferrand, France, 63003
      • Marseille, France, 13385
      • Nantes Cedex, France, 44093
      • Pessac, France, 33604
      • 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, 400 016
      • Mumbai, India, 400 026
      • Pune, India, 411 030
      • Pune, India, 411 004
      • Visakhapatnam, India, 530 002
  • Italy
      • Chieti, Italy, 66013
      • Grosseto, Italy, 58100
      • Rome, Italy, 00163
      • Rome, Italy, 00185
  • Poland
      • Bydgoszcz, 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, 04080
      • Kiev, Ukraine, 04114
      • Lugansk, Ukraine, 91045
      • Lviv, Ukraine, 79010
      • Vinnitsia, Ukraine, 21005
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
      • Blackburn, United Kingdom, BB2 3HH
      • London, United Kingdom, NW3 20G
      • Newcastle, United Kingdom, NE4 6BE
      • North Shields, United Kingdom, NE21 8NH
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
      • Phoenix, Arizona, United States, 85013
      • Tucson, Arizona, United States, 84724
    • 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
      • Pasadena, California, United States, 91105
      • Reseda, California, United States, 91335
      • Sunnyvale, California, United States, 94085
      • Ventura, California, United States, 93003
    • Colorado
      • Englewood, Colorado, United States, 80113
    • Connecticut
      • Danbury, Connecticut, United States, 06810
      • Fairfield, Connecticut, United States, 06824
      • Farmington, Connecticut, United States, 06030
    • 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, 33980
      • Saint Petersburg, Florida, United States, 33701
      • Sarasota, Florida, United States, 34233
      • Tampa, Florida, United States, 33606
    • Georgia
      • Augusta, Georgia, United States, 30912
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Glenview, Illinois, United States, 60026
      • Springfield, Illinois, United States, 62794
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Maine
      • Scarborough, Maine, United States, 04074
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Clinton Township, Michigan, United States, 48037
      • Detroit, Michigan, United States, 48201
      • East Lansing, Michigan, United States, 48824
      • Roseville, Michigan, United States, 48066
      • Traverse City, Michigan, United States, 49684
      • West Bloomfield, Michigan, United States, 48334
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Saint Louis, Missouri, United States, 63110
    • Montana
      • Missoula, Montana, United States, 59802
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • 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
    • 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
    • Ohio
      • Cincinnati, Ohio, United States, 45210
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
      • Toledo, Ohio, United States, 43614
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
      • Philadelphia, Pennsylvania, United States, 19131
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
    • Texas
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Alexandria, Virginia, United States, 22311
      • Richmond, Virginia, United States, 23229
      • Roanoke, Virginia, United States, 24018
      • Virginia Beach, Virginia, United States, 23456
    • Washington
      • Kirkland, Washington, United States, 98034
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Time Frame: From first to last study drug dose plus 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ACADIA Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

October 26, 2007

First Submitted That Met QC Criteria

October 26, 2007

First Posted (Estimate)

October 29, 2007

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-103-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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