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

Parkinson Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04377945
• Other study ID #: BK-JM-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 28, 2021
• Est. completion date: January 3, 2025

Study information

• Verified date: February 2024
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: January 3, 2025
• Est. primary completion date: January 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• Part 1, JM-010 component Group A
JM-010 component Group A
• Part 1, JM-010 component Group B
JM-010 component Group B
• Part 1, JM-010 component Group C
JM-010 component Group C
• Part 1, Placebo Group
Placebo Group
• Part 2, JM-010 combination Group A
JM-010 combination Group A
• Part 2, JM-010 combination Group B
JM-010 combination Group B
• Part 2, JM-010 component Group C
JM-010 component Group C
• Part 2, Placebo Group
Placebo Group

Locations

Country	Name	City	State
United States	Bukwang Investigator site	Detroit	Michigan
United States	Bukwang Investigator site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Dyskinesia Rating Scale (UDysRS)	Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia	Week 12
Secondary	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	Week 12