Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components

Last updated: January 13, 2023
Sponsor: Bukwang Pharmaceutical
Overall Status: Active - Recruiting

Phase

2

Condition

Dyskinesias

Parkinson's Disease

Treatment

Part 1, Placebo Group

Part 1, JM-010 component Group A

Part 1, JM-010 component Group C

Clinical Study ID

NCT04377945
  • Ages 18-85
  • All Genders

Study Summary

This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
  • Is male or female, between 18 and 85 years of age at Screening Visit.
  • Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
  • Has experienced dyskinesia
  • Has stable peak-effect dyskinesia
  • Has more than one hour of "ON" time with troublesome dyskinesia

Exclusion

Exclusion Criteria:

  • Has undergone surgery for the treatment of PD
  • Has a current diagnosis of Substance Use
  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  • Has current seizure disorders requiring treatment with anticonvulsants.

Other criteria related to other medical conditions to be referred to the protocol.

Study Design

Total Participants: 188
Treatment Group(s): 8
Primary Treatment: Part 1, Placebo Group
Phase: 2
Study Start date:
April 28, 2021
Estimated Completion Date:
July 17, 2024

Study Description

This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.

Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

Connect with a study center

  • Xenoscience, Inc.

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Tucson Neuroscience Research

    Tucson, Arizona 85710
    United States

    Active - Recruiting

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • University of California, Irvine

    Irvine, California 92697
    United States

    Active - Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • SC3 Research - Pasadena

    Pasadena, California 91105
    United States

    Active - Recruiting

  • SC3 Research - Reseda

    Reseda, California 91335
    United States

    Active - Recruiting

  • University of California Davis Neurology Department

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • University of Miami - Miller School of Medicine (Uhealth at Boca Raton)

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Neurology Associates, PA

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Medical Professional Clinical Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Parkinsons Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida 33980-8421
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Kansas Medical Center- KUMC

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kentucky Research Foundation

    Lexington, Kentucky 40536-0284
    United States

    Active - Recruiting

  • Wayne State University

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Neurology Consultants of Dallas

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Inova Medical Group Neurology II

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • VCU Parkinsons Disease & Movement Disorders Center

    Henrico, Virginia 23233
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Active - Recruiting

  • Evergreen Health

    Kirkland, Washington 98034
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.