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

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ClinicalTrials.gov Identifier: NCT04377945
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

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.

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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 : December 12, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 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 80 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.


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
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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: November 8, 2021
Last Verified: November 2021
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