The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study

July 30, 2021 updated by: ACADIA Pharmaceuticals Inc.

Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)

To examine the current disease progression of PDP, the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers

Study Overview

Status

Status

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

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.

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.
Observational

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.
764

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

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • North Central Neurology Associates, P.C.
    • Alaska
      • Anchorage, Alaska, United States, 99501
        • Peak Neurology and Sleep Medicine, LLC
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Movement Disorders Center of Arizona
    • California
      • Laguna Hills, California, United States, 92653
        • Brain and Elective Spine Treatment Center
      • Los Gatos, California, United States, 95032
        • Silicon Valley Parkinson Center Inc.
      • Menlo Park, California, United States, 94025
        • Parkinson's Disease and Movement Disorder of Silicon Valley
      • Northridge, California, United States, 91326
        • Jeri Yvonne Movement Disorders Neurology, Inc.
      • Santa Monica, California, United States, 90404
        • Pacific Movement Disorders Center
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Colorado Neurological Institute
    • Connecticut
      • New Britain, Connecticut, United States, 06053
        • Hospital for Special Care
    • Florida
      • Boca Raton, Florida, United States, 33487
        • SFM Clinical Research, LLC
      • Boca Raton, Florida, United States, 33428
        • Neurology Offices of S. Florina
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
      • Miami, Florida, United States, 33175
        • Intermed Medical Research Center
      • Port Charlotte, Florida, United States, 33952
        • Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida
      • Saint Petersburg, Florida, United States, 34309
        • Nova Clinical Research, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Ms Center Of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Glen Carbon, Illinois, United States, 62034
        • Southern Illinois Associates, LLC
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
    • Kansas
      • Leawood, Kansas, United States, 66206
        • Psychiatry Associates of Kansas City
      • Overland Park, Kansas, United States, 66212
        • Overland Park Surgical Specialties, LLC
    • Louisiana
      • Gray, Louisiana, United States, 70359
        • Southeast Neuroscience Center
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center - New Orleans
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Parkinsons & Movement Disorders Center of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 00211
        • Tufts Medical Center, Inc.
      • Foxboro, Massachusetts, United States, 02035
        • Neurology Center of New England
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts, Worcester
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State Neurology
      • Farmington Hills, Michigan, United States, 48334
        • The Parkinson's and Movement Disorder Center
      • Traverse City, Michigan, United States, 49684
        • Cornelius Robens, MD, PLLC
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Health System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Neurology Consultants of Nebraska
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Neurology Center of Las Vegas
      • Las Vegas, Nevada, United States, 89104
        • Las Vegas Neurology Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • The Cooper Health System
      • Edison, New Jersey, United States, 08820
        • JFK Neuroscience Institute
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers, Robert Wood Johnson
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center, Inc.
      • Rochester, New York, United States, 14642
        • University of Rochester Neurology
      • Staten Island, New York, United States, 10306
        • Alpha Neurology PC
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Excel Psychiatric Associates
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, Pa
    • Ohio
      • Akron, Ohio, United States, 44320
        • Neurology and Neuroscience Associates, Inc.
      • Centerville, Ohio, United States, 45459
        • Dayton Center for Neurological Disorders
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cuyahoga Falls, Ohio, United States, 44223
        • Renga A. Pakeeree, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Allegheny-Singer Research Institute
    • Texas
      • Baytown, Texas, United States, 77521
        • Jacinto Medical Group
      • Bedford, Texas, United States, 76021
        • North Texas Movement Disorders Institute
      • Sherman, Texas, United States, 75090
        • Texas Institute for Neurological Disorders (Texoma Neurology)
      • Tyler, Texas, United States, 75701
        • East Texas Medical Center Healthcare Associates
      • Tyler, Texas, United States, 75702
        • CHRISTUS Trinity Frances Neuroscience Institute
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Medical Faculty Associates, Inc.
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Christiansburg, Virginia, United States, 24073
        • Blacksburg Neurology, PC
      • Norfolk, Virginia, United States, 23502
        • Neurology Specialists
      • Richmond, Virginia, United States, 23226
        • Henrico Doctors' Neurology Associates LLC
    • Washington
      • Auburn, Washington, United States, 98002
        • Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center
      • Spokane, Washington, United States, 99202
        • Inland Northwest Research, LLC
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Vaught Neurological Services, PLLC
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center, Inc.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients experiencing hallucinations and delusions as a complication of Parkinson's Disease.

Description

Inclusion Criteria:

  1. Adult males and females ≥ 18 with PDP
  2. Ability to understand and read English
  3. Patient is willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf
  4. Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes

Exclusion Criteria:

  1. Patient is unwilling to participate in the non-interventional study
  2. Patient is currently participating in or is planning to participate in an investigational clinical trial

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1: Parkinson Disease Psychosis (PDP) patients
PDP patients not treated with an antipsychotic at the time of enrollment
Other: Real-world, non-interventional
N/A - non-interventional
Group 2: Parkinson Disease Psychosis (PDP) patients
PDP patients treated with an antipsychotic (other than NUPLAZID®) at the time of enrollment
Other: Real-world, non-interventional
N/A - non-interventional
Group 3: Parkinson Disease Psychosis (PDP) patients
PDP patients treated with NUPLAZID® at the time of enrollment
Other: Real-world, non-interventional
N/A - non-interventional

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
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)
Time Frame: Approximately 36 months
Describe the safety and effectiveness of antipsychotic therapies and other treatment approaches in the management of PDP. Describe comparative clinical, economic, and humanistic outcomes of treatment approaches for both patients and caregivers, in the context of real-world medical practice settings.
Approximately 36 months

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.

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 (Actual)

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.
March 30, 2017

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.
March 8, 2021

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.
March 8, 2021

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).
May 11, 2017

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.
May 11, 2017

First Posted (Actual)

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.
May 15, 2017

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.
August 6, 2021

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.
July 30, 2021

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.
July 1, 2021

More Information

Terms related to this study

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-NIS-001

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

No

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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