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

Last updated: June 14, 2024
Sponsor: Bukwang Pharmaceutical
Overall Status: Terminated

Phase

2

Condition

Dyskinesias

Treatment

Part 2, JM-010 combination Group B

Part 1, JM-010 component Group B

Part 1, JM-010 component Group A

Clinical Study ID

NCT04377945
BK-JM-201
  • 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 toScreening 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: 41
Treatment Group(s): 8
Primary Treatment: Part 2, JM-010 combination Group B
Phase: 2
Study Start date:
April 28, 2021
Estimated Completion Date:
February 14, 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

  • Bukwang Investigator site

    Fountain Valley, California 92704
    United States

    Site Not Available

  • Bukwang Investigator site

    Fullerton, California 92835
    United States

    Site Not Available

  • Bukwang Investigator site

    Sacramento, California 95817
    United States

    Site Not Available

  • Bukwang Investigator site

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Bukwang Investigator site

    Maitland, Florida 32751
    United States

    Site Not Available

  • Bukwang Investigator site

    Miami, Florida 33165
    United States

    Site Not Available

  • Bukwang Investigator Site

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • Bukwang Investigator site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Bukwang Investigator site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Bukwang Investigator site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Bukwang Investigator site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Bukwang Investigator site

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • Bukwang Investigator site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Bukwang Investigator site

    Houston, Texas 77030
    United States

    Site Not Available

  • Bukwang Investigator site

    Kirkland, Washington 98033
    United States

    Site Not Available

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.