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

Primary Purpose

Dyskinesias, Parkinson Disease

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Part 1, JM-010 component Group A

Part 1, JM-010 component Group B

Part 1, JM-010 component Group C

Part 1, Placebo Group

Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C

Part 2, Placebo Group

About this trial

This is an interventional treatment trial for Dyskinesias

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bukwang Investigator siteRecruiting
Bukwang Investigator site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1, JM-010 component Group A

Part 1, JM-010 component Group B

Part 1, JM-010 component Group C

Part 1, Placebo Group

Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C

Part 2, Placebo Group

Arm Description

Part 1, JM-010 component Group A

Part 1, JM-010 component Group B

Part 1, JM-010 component Group C

Part 1, Placebo Group

Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C

Part 2, Placebo Group

Outcomes

Primary Outcome Measures

Unified Dyskinesia Rating Scale (UDysRS)

Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia

Secondary Outcome Measures

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment

Full Information

NCT ID

NCT04377945

First Posted

May 4, 2020

Last Updated

January 11, 2023

Sponsor

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT04377945

Brief Title

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

Acronym

SHINE

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2021 (Actual)

Primary Completion Date

July 17, 2024 (Anticipated)

Study Completion Date

July 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bukwang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyskinesias, Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1, JM-010 component Group A

Arm Type

Experimental

Arm Description

Part 1, JM-010 component Group A

Arm Title

Part 1, JM-010 component Group B

Arm Type

Experimental

Arm Description

Part 1, JM-010 component Group B

Arm Title

Part 1, JM-010 component Group C

Arm Type

Experimental

Arm Description

Part 1, JM-010 component Group C

Arm Title

Part 1, Placebo Group

Arm Type

Placebo Comparator

Arm Description

Part 1, Placebo Group

Arm Title

Part 2, JM-010 combination Group A

Arm Type

Experimental

Arm Description

Part 2, JM-010 combination Group A

Arm Title

Part 2, JM-010 combination Group B

Arm Type

Experimental

Arm Description

Part 2, JM-010 combination Group B

Arm Title

Part 2, JM-010 component Group C

Arm Type

Experimental

Arm Description

Part 2, JM-010 component Group C

Arm Title

Part 2, Placebo Group

Arm Type

Placebo Comparator

Arm Description

Part 2, Placebo Group

Intervention Type

Drug

Intervention Name(s)

Part 1, JM-010 component Group A

Intervention Description

JM-010 component Group A

Intervention Type

Drug

Intervention Name(s)

Part 1, JM-010 component Group B

Intervention Description

JM-010 component Group B

Intervention Type

Drug

Intervention Name(s)

Part 1, JM-010 component Group C

Intervention Description

JM-010 component Group C

Intervention Type

Drug

Intervention Name(s)

Part 1, Placebo Group

Intervention Description

Placebo Group

Intervention Type

Drug

Intervention Name(s)

Part 2, JM-010 combination Group A

Intervention Description

JM-010 combination Group A

Intervention Type

Drug

Intervention Name(s)

Part 2, JM-010 combination Group B

Intervention Description

JM-010 combination Group B

Intervention Type

Drug

Intervention Name(s)

Part 2, JM-010 component Group C

Intervention Description

JM-010 component Group C

Intervention Type

Drug

Intervention Name(s)

Part 2, Placebo Group

Intervention Description

Placebo Group

Primary Outcome Measure Information:

Title

Unified Dyskinesia Rating Scale (UDysRS)

Description

Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Description

Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sooyeon Park

Phone

82-2-828-8240

bk_jm010@bukwang.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sooyeon Park

Organizational Affiliation

Bukwang Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

Bukwang Investigator site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Individual Site Status

Recruiting

Facility Name

Bukwang Investigator site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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