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

NCT03152292 | Terminated

• 1 other identifier: ACP-NIS-001
• Study Type: observational
• Target: 764
• Locations: 1 country
• Sites: 69

Brief Summary

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

Conditions

Parkinson Disease Psychosis

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (3)

Group 1: Parkinson Disease Psychosis (PDP) patients

PDP patients not treated with an antipsychotic at the time of enrollment

Other: Real-world, 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

Group 3: Parkinson Disease Psychosis (PDP) patients

PDP patients treated with NUPLAZID® at the time of enrollment

Other: Real-world, non-interventional

Interventions

Real-world, non-interventional OTHER

N/A - non-interventional

Group 1: Parkinson Disease Psychosis (PDP) patients; Group 2: Parkinson Disease Psychosis (PDP) patients; Group 3: Parkinson Disease Psychosis (PDP) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult males and females ≥ 18 with PDP
• Ability to understand and read English
• 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
• Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes

You may not qualify if:

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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (69)

North Central Neurology Associates, P.C.

Cullman, Alabama, 35058, United States

Location

Peak Neurology and Sleep Medicine, LLC

Anchorage, Alaska, 99501, United States

Location

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Brain and Elective Spine Treatment Center

Laguna Hills, California, 92653, United States

Location

Silicon Valley Parkinson Center Inc.

Los Gatos, California, 95032, United States

Location

Parkinson's Disease and Movement Disorder of Silicon Valley

Menlo Park, California, 94025, United States

Location

Jeri Yvonne Movement Disorders Neurology, Inc.

Northridge, California, 91326, United States

Location

Pacific Movement Disorders Center

Santa Monica, California, 90404, United States

Location

Colorado Neurological Institute

Greenwood Village, Colorado, 80111, United States

Location

Hospital for Special Care

New Britain, Connecticut, 06053, United States

Location

Neurology Offices of S. Florina

Boca Raton, Florida, 33428, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.

Boca Raton, Florida, 33486, United States

Location

SFM Clinical Research, LLC

Boca Raton, Florida, 33487, United States

Location

Intermed Medical Research Center

Miami, Florida, 33175, United States

Location

Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, 33952, United States

Location

NOVA Clinical Research, LLC

St. Petersburg, Florida, 34309, United States

Location

MS Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Southern Illinois Associates, LLC

Glen Carbon, Illinois, 62034, United States

Location

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

American Health Network of Indiana

Avon, Indiana, 46123, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

Psychiatry Associates of Kansas City

Leawood, Kansas, 66206, United States

Location

Overland Park Surgical Specialties, LLC

Overland Park, Kansas, 66212, United States

Location

Southeast Neuroscience Center

Gray, Louisiana, 70359, United States

Location

LSU Health Sciences Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Parkinsons & Movement Disorders Center of Maryland

Elkridge, Maryland, 21075, United States

Location

Tufts Medical Center, Inc.

Boston, Massachusetts, 00211, United States

Location

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Michigan State Neurology

East Lansing, Michigan, 48824, United States

Location

The Parkinson's and Movement Disorder Center

Farmington Hills, Michigan, 48334, United States

Location

Cornelius Robens, MD, PLLC

Traverse City, Michigan, 49684, United States

Location

Henry Ford Health System

West Bloomfield, Michigan, 48322, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Neurology Consultants of Nebraska

Omaha, Nebraska, 68131, United States

Location

Las Vegas Neurology Center

Las Vegas, Nevada, 89104, United States

Location

Neurology Center of Las Vegas

Las Vegas, Nevada, 89128, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

JFK Neuroscience Institute

Edison, New Jersey, 08820, United States

Location

Rutgers, Robert Wood Johnson

New Brunswick, New Jersey, 08903, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226, United States

Location

University of Rochester Neurology

Rochester, New York, 14642, United States

Location

Alpha Neurology PC

Staten Island, New York, 10306, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Excel Psychiatric Associates

Huntersville, North Carolina, 28078, United States

Location

Raleigh Neurology Associates, PA

Raleigh, North Carolina, 27607, United States

Location

Neurology and Neuroscience Associates, Inc.

Akron, Ohio, 44320, United States

Location

Dayton Center for Neurological Disorders

Centerville, Ohio, 45459, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Renga A. Pakeeree, MD

Cuyahoga Falls, Ohio, 44223, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Allegheny-Singer Research Institute

East Providence, Rhode Island, 02914, United States

Location

Jacinto Medical Group

Baytown, Texas, 77521, United States

Location

North Texas Movement Disorders Institute

Bedford, Texas, 76021, United States

Location

Texas Institute for Neurological Disorders (Texoma Neurology)

Sherman, Texas, 75090, United States

Location

East Texas Medical Center Healthcare Associates

Tyler, Texas, 75701, United States

Location

CHRISTUS Trinity Frances Neuroscience Institute

Tyler, Texas, 75702, United States

Location

Medical Faculty Associates, Inc.

Arlington, Virginia, 22203, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Blacksburg Neurology, PC

Christiansburg, Virginia, 24073, United States

Location

Neurology Specialists

Norfolk, Virginia, 23502, United States

Location

Henrico Doctors' Neurology Associates LLC

Richmond, Virginia, 23226, United States

Location

Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center

Auburn, Washington, 98002, United States

Location

Inland Northwest Research, LLC

Spokane, Washington, 99202, United States

Location

Vaught Neurological Services, PLLC

Beckley, West Virginia, 25801, United States

Location

Gundersen Lutheran Medical Center, Inc.

La Crosse, Wisconsin, 54601, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: March 30, 2017
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (69)