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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 : Recruiting
First Posted : May 7, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date November 8, 2021
Actual Study Start Date  ICMJE April 28, 2021
Estimated Primary Completion Date December 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Week 12 ]
Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 12 Weeks(Part 2) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Unified Dyskinesia Rating Scale (UDysRS) [ 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 (MDS-UPDRS) [ Time Frame: Week 1, 2, and 3(Part 1), Week 2, 4, 8, and 12(Part 2) ]
  • Clinician's Global Impression-Change (CGI-C) score [ Time Frame: Week 3(Part 1), Week 12(Part 2) ]
  • Hauser diary [ Time Frame: Week 2, 4, 8, and 12(Part 2) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • Dyskinesias
  • Parkinson Disease
Intervention  ICMJE
  • Drug: Part 1, JM-010 component Group A
    JM-010 component Group A
  • Drug: Part 1, JM-010 component Group B
    JM-010 component Group B
  • Drug: Part 1, JM-010 component Group C
    JM-010 component Group C
  • Drug: Part 1, Placebo Group
    Placebo Group
  • Drug: Part 2, JM-010 combination Group A
    JM-010 combination Group A
  • Drug: Part 2, JM-010 combination Group B
    JM-010 combination Group B
  • Drug: Part 2, JM-010 component Group C
    JM-010 component Group C
  • Drug: Part 2, Placebo Group
    Placebo Group
Study Arms  ICMJE
  • Experimental: Part 1, JM-010 component Group A
    Part 1, JM-010 component Group A
    Intervention: Drug: Part 1, JM-010 component Group A
  • Experimental: Part 1, JM-010 component Group B
    Part 1, JM-010 component Group B
    Intervention: Drug: Part 1, JM-010 component Group B
  • Experimental: Part 1, JM-010 component Group C
    Part 1, JM-010 component Group C
    Intervention: Drug: Part 1, JM-010 component Group C
  • Placebo Comparator: Part 1, Placebo Group
    Part 1, Placebo Group
    Intervention: Drug: Part 1, Placebo Group
  • Experimental: Part 2, JM-010 combination Group A
    Part 2, JM-010 combination Group A
    Intervention: Drug: Part 2, JM-010 combination Group A
  • Experimental: Part 2, JM-010 combination Group B
    Part 2, JM-010 combination Group B
    Intervention: Drug: Part 2, JM-010 combination Group B
  • Experimental: Part 2, JM-010 component Group C
    Part 2, JM-010 component Group C
    Intervention: Drug: Part 2, JM-010 component Group C
  • Placebo Comparator: Part 2, Placebo Group
    Part 2, Placebo Group
    Intervention: Drug: Part 2, Placebo Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
188
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sooyeon Park 82-2-828-8240 bk_jm010@bukwang.co.kr
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377945
Other Study ID Numbers  ICMJE BK-JM-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bukwang Pharmaceutical
Study Sponsor  ICMJE Bukwang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sooyeon Park Bukwang Pharmaceutical
PRS Account Bukwang Pharmaceutical
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP