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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
459

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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