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

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
Sponsor
Bukwang Pharmaceutical
Links
Sign up for this study
ID
NCT04377945
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 41 people participating
Last Updated