SHINE Study: Testing a New Oral Drug to Treat Parkinson's Disease With Dyskinesia

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a study on Dyskinesia Parkinson's Disease

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Detroit, Michigan and other locations
Dates
study started
completion around

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components

Details

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.

Keywords

Dyskinesias, Parkinson Disease, Part 1, JM-010 component Group A, Part 1, JM-010 component Group B, Part 1, JM-010 component Group C, Part 2, JM-010 combination Group A, Part 2, JM-010 combination Group B, Part 2, JM-010 component Group C

Eligibility

You can join if…

Open to people ages 18-85

  • 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

You CAN'T join if...

  • 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.

Locations

  • Bukwang Investigator site
    Detroit Michigan 48201 United States
  • Bukwang Investigator site
    Miami Florida 33165 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bukwang Pharmaceutical
Links
Sign up for this study
ID
NCT04377945
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 148 study participants
Last Updated