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Trial record 1 of 1 for:    NCT04377945
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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 : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : September 23, 2020
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 Parkinsons' Disease.

Condition or disease Intervention/treatment Phase
Dyskinesia, Drug-Induced 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, Placebo Group Drug: Part 2, JM-010 component Group C 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 moderate to severe dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study. Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.

The screening assessment period will be from 1 week to 6 weeks duration. For both Part 1 and Part 2, subjects deemed eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1:1 ratio to receive one of the treatments, as per the double-blind 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
Estimated Study Start Date : December 1, 2020
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

Placebo Comparator: Part 2, Placebo Group
Part 2, Placebo Group
Drug: Part 2, Placebo Group
Placebo Group

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




Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 12 Weeks (Part 2) ]
    Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia.


Secondary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Week 1, 2, and 3 (Part 1), Week 2, 4, 8, and 12 (Part 2) ]
    Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia.

  2. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Week 1, 2, and 3 (Part 1), Week 2, 4, 8, and 12 (Part 2) ]
    Movement Disorder Society Unified Parkinson's Disease Rating Scale (Scoring range: 0-132), higher score indicates more severe motor impairment.

  3. Clinician's Global Impression-Change (CGI-C) score [ Time Frame: Week 3 (Part 1), Week 12 (Part 2) ]
    Clinician's Global Impression-Change (Scoring range: 0-7), 0=not assessed; 1=very much improved; 2=much improved; 3=a little improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.

  4. Hauser diary [ Time Frame: Week 2, 4, 8, and 12 (Part 2) ]
    Hauser Diary (Recording total time with dyskinesia changes)



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 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 and requires treatment with and shows responsiveness to levodopa.
  • Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
  • Has stable peak-effect dyskinesia
  • Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
  • Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day

Exclusion Criteria:

  • Has undergone surgery for the treatment of PD
  • Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),
  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  • Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study
  • Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
  • Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).
  • Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia.

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: Yoonjung Choi 82-2-828-8114 yoon.jung.choi@bukwang.co.kr
Contact: Hyejin Roh 82-2-828-8114 hye.jin.roh@bukwang.co.kr

Locations
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United States, California
Bukwang Investigator site
Fountain Valley, California, United States, 92704
Bukwang Investigator site
Fullerton, California, United States, 92835
Bukwang Investigator site
Sacramento, California, United States, 95817
United States, Florida
Bukwang Investigator site
Boca Raton, Florida, United States, 33486
Bukwang Investigator site
Maitland, Florida, United States, 32751
Bukwang Investigator Site
Port Charlotte, Florida, United States, 33980
Bukwang Investigator site
Tampa, Florida, United States, 33612
United States, Kansas
Bukwang Investigator site
Kansas City, Kansas, United States, 66160
United States, Kentucky
Bukwang Investigator site
Lexington, Kentucky, United States, 40536
United States, Michigan
Bukwang Investigator site
West Bloomfield, Michigan, United States, 48322
Contact: Bukwang         
United States, New Jersey
Bukwang Investigator site
New Brunswick, New Jersey, United States, 08901
United States, Texas
Bukwang Investigator site
Houston, Texas, United States, 77030
United States, Washington
Bukwang Investigator site
Kirkland, Washington, United States, 98033
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Study Director: Yoonjung Choi 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: September 23, 2020
Last Verified: September 2020
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
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning