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Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT04377945•Bukwang Pharmaceutical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

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 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

Key Dates

Start Date

April 28, 2021

Primary Completion Date

February 14, 2024

Completion Date

February 14, 2024

Last Updated

June 17, 2024

Enrollment

ACTUAL participants

Conditions

DyskinesiasParkinson Disease

Interventions

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

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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