Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03152292
Other study ID # ACP-NIS-001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 30, 2017
Est. completion date March 8, 2021

Study information

Verified date July 2021
Source ACADIA Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 764
Est. completion date March 8, 2021
Est. primary completion date March 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Real-world, non-interventional
N/A - non-interventional

Locations

Country Name City State
United States Neurology and Neuroscience Associates, Inc. Akron Ohio
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Dent Neurosciences Research Center, Inc. Amherst New York
United States Peak Neurology and Sleep Medicine, LLC Anchorage Alaska
United States Medical Faculty Associates, Inc. Arlington Virginia
United States MS Center of Atlanta Atlanta Georgia
United States Cascade Surgery Associates, PLLC DBA Northwest Neurology Electrodiagnostic Center Auburn Washington
United States American Health Network of Indiana Avon Indiana
United States Eastern Maine Medical Center Bangor Maine
United States Jacinto Medical Group Baytown Texas
United States Vaught Neurological Services, PLLC Beckley West Virginia
United States North Texas Movement Disorders Institute Bedford Texas
United States Neurology Offices of S. Florina Boca Raton Florida
United States Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc. Boca Raton Florida
United States SFM Clinical Research, LLC Boca Raton Florida
United States Tufts Medical Center, Inc. Boston Massachusetts
United States The Cooper Health System Camden New Jersey
United States Dayton Center for Neurological Disorders Centerville Ohio
United States University of Virginia Charlottesville Virginia
United States Rush University Medical Center Chicago Illinois
United States Blacksburg Neurology, PC Christiansburg Virginia
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States North Central Neurology Associates, P.C. Cullman Alabama
United States Renga A. Pakeeree, MD Cuyahoga Falls Ohio
United States Michigan State Neurology East Lansing Michigan
United States Allegheny-Singer Research Institute East Providence Rhode Island
United States JFK Neuroscience Institute Edison New Jersey
United States Parkinsons & Movement Disorders Center of Maryland Elkridge Maryland
United States The Parkinson's and Movement Disorder Center Farmington Hills Michigan
United States Fort Wayne Neurological Center Fort Wayne Indiana
United States Neurology Center of New England Foxboro Massachusetts
United States Southern Illinois Associates, LLC Glen Carbon Illinois
United States Southeast Neuroscience Center Gray Louisiana
United States Colorado Neurological Institute Greenwood Village Colorado
United States Excel Psychiatric Associates Huntersville North Carolina
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Gundersen Lutheran Medical Center, Inc. La Crosse Wisconsin
United States Brain and Elective Spine Treatment Center Laguna Hills California
United States Las Vegas Neurology Center Las Vegas Nevada
United States Neurology Center of Las Vegas Las Vegas Nevada
United States Psychiatry Associates of Kansas City Leawood Kansas
United States Silicon Valley Parkinson Center Inc. Los Gatos California
United States Parkinson's Disease and Movement Disorder of Silicon Valley Menlo Park California
United States Intermed Medical Research Center Miami Florida
United States Hospital for Special Care New Britain Connecticut
United States Rutgers, Robert Wood Johnson New Brunswick New Jersey
United States LSU Health Sciences Center - New Orleans New Orleans Louisiana
United States Neurology Specialists Norfolk Virginia
United States Jeri Yvonne Movement Disorders Neurology, Inc. Northridge California
United States Neurology Consultants of Nebraska Omaha Nebraska
United States Overland Park Surgical Specialties, LLC Overland Park Kansas
United States Ramon A. Gil, MD, PA, DBA Parkinson's Disease Treatment Center of SW Florida Port Charlotte Florida
United States Maine Medical Center Portland Maine
United States Raleigh Neurology Associates, PA Raleigh North Carolina
United States Henrico Doctors' Neurology Associates LLC Richmond Virginia
United States University of Rochester Neurology Rochester New York
United States NOVA Clinical Research, LLC Saint Petersburg Florida
United States Pacific Movement Disorders Center Santa Monica California
United States Movement Disorders Center of Arizona Scottsdale Arizona
United States Texas Institute for Neurological Disorders (Texoma Neurology) Sherman Texas
United States Inland Northwest Research, LLC Spokane Washington
United States Alpha Neurology PC Staten Island New York
United States Cornelius Robens, MD, PLLC Traverse City Michigan
United States CHRISTUS Trinity Frances Neuroscience Institute Tyler Texas
United States East Texas Medical Center Healthcare Associates Tyler Texas
United States New York Medical College Valhalla New York
United States Henry Ford Health System West Bloomfield Michigan
United States Central DuPage Hospital Winfield Illinois
United States University of Massachusetts, Worcester Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05824728 - Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis Phase 2
Withdrawn NCT05344365 - A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis Phase 2
Recruiting NCT05357612 - Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases Phase 4
Completed NCT06450184 - Bioequivalence Study of Pimavanserin 34 mg Capsule Phase 1
Completed NCT04292223 - Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis Phase 4
Completed NCT02969369 - A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis Phase 2
Not yet recruiting NCT05995782 - A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418 Phase 1
Recruiting NCT04592965 - Hallucinations in Parkinson's Disease N/A
Recruiting NCT04579887 - Presence Hallucination in Parkinson's Disease N/A
Completed NCT05240339 - Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)
Recruiting NCT03661125 - SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis Early Phase 1