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

Phase 2TerminatedNCT04377945

Bukwang Pharmaceutical41 enrolled

Overview

This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dyskinesias Parkinson Disease

Interventions

Part 1, JM-010 component Group ADRUG

JM-010 component Group A

Part 1, JM-010 component Group BDRUG

JM-010 component Group B

Part 1, JM-010 component Group CDRUG

JM-010 component Group C

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (2)

Bukwang Investigator site

Miami, Florida, United States

Bukwang Investigator site

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Unified Dyskinesia Rating Scale (UDysRS)

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

Time frame: Week 12

Secondary Outcomes

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

Time frame: Week 12

Data from ClinicalTrials.gov

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