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

Bukwang Pharmaceutical1 site in 1 country41 target enrollmentApril 28, 2021

InterventionsPart 1, JM-010 component Group B Part 1, JM-010 component Group C Part 1, JM-010 component Group A 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

DrugsPart 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

Overview

Phase: Phase 2
Intervention: Part 1, JM-010 component Group B
Conditions: Dyskinesias
Sponsor: Bukwang Pharmaceutical
Enrollment: 41
Locations: 1
Primary Endpoint: Unified Dyskinesia Rating Scale (UDysRS)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 28, 2021

End Date

February 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bukwang Pharmaceutical

Responsible Party

Sponsor

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.