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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377945
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dyskinesias Parkinson Disease Drug: Part 1, JM-010 component Group A Drug: Part 1, JM-010 component Group B Drug: Part 1, JM-010 component Group C Drug: Part 1, Placebo Group Drug: Part 2, JM-010 combination Group A Drug: Part 2, JM-010 combination Group B Drug: Part 2, JM-010 component Group C Drug: Part 2, Placebo Group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : July 17, 2024
Estimated Study Completion Date : July 17, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1, JM-010 component Group A
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
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
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
Part 1, Placebo Group
 Drug: Part 1, Placebo Group
Placebo Group
Experimental: Part 2, JM-010 combination Group A
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
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
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
Part 2, Placebo Group
 Drug: Part 2, Placebo Group
Placebo Group


Outcome Measures
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Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Week 12 ]
    Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377945


Contacts
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Contact: Sooyeon Park 82-2-828-8240 bk_jm010@bukwang.co.kr

Locations
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United States, Florida
Bukwang Investigator site Recruiting
Miami, Florida, United States, 33165
United States, Michigan
Bukwang Investigator site Not yet recruiting
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Study Director: Sooyeon Park Bukwang Pharmaceutical
More Information
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Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04377945    
Other Study ID Numbers: BK-JM-201
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations