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

Sponsor
Bukwang Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04377945
Collaborator
(none)
188
Enrollment
2
Locations
8
Arms
20.1
Anticipated Duration (Months)
94
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

For more information, please visit:

www.SHINEParkinsonsStudy.com

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 28, 2021
Anticipated Primary Completion Date :
Dec 12, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Unified Dyskinesia Rating Scale (UDysRS) [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) [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

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bukwang Investigator site Miami Florida United States 33165
2 Bukwang Investigator site Detroit Michigan United States 48201

Sponsors and Collaborators

  • Bukwang Pharmaceutical

Investigators

  • Study Director: Sooyeon Park, Bukwang Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT04377945
Other Study ID Numbers:
  • BK-JM-201
First Posted:
May 7, 2020
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias

Study Results

No Results Posted as of Apr 1, 2022