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

June 14, 2024 updated by: Bukwang Pharmaceutical

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1, JM-010 component Group A
Drug: Part 1, JM-010 component Group A
JM-010 component Group A
Experimental: Part 1, JM-010 component Group B
Drug: Part 1, JM-010 component Group B
JM-010 component Group B
Experimental: Part 1, JM-010 component Group C
Drug: Part 1, JM-010 component Group C
JM-010 component Group C
Placebo Comparator: Part 1, Placebo Group
Drug: Part 1, Placebo Group
Placebo Group
Experimental: Part 2, JM-010 combination Group A
Drug: Part 2, JM-010 combination Group A
JM-010 combination Group A
Experimental: Part 2, JM-010 combination Group B
Drug: Part 2, JM-010 combination Group B
JM-010 combination Group B
Experimental: Part 2, JM-010 component Group C
Drug: Part 2, JM-010 component Group C
JM-010 component Group C
Placebo Comparator: Part 2, Placebo Group
Drug: Part 2, Placebo Group
Placebo Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Dyskinesia Rating Scale (UDysRS)
Time Frame: Week 12
Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: Week 12
Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Investigators

  • Study Director: Sooyeon Park, Bukwang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

February 14, 2024

Study Completion (Actual)

February 14, 2024

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK-JM-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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