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

Phase 2

Terminated

• Conditions: Dyskinesias; Parkinson Disease
• Interventions: Drug: Part 1, JM-010 component Group B; Drug: Part 2, Placebo Group; Drug: Part 1, JM-010 component Group A; Drug: Part 1, Placebo Group; Drug: Part 1, JM-010 component Group C; Drug: Part 2, JM-010 combination Group A; Drug: Part 2, JM-010 combination Group B; Drug: Part 2, JM-010 component Group C

• Registration Number: NCT04377945
• Lead Sponsor: Bukwang Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Study Start: 2021-04-28
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1, JM-010 component Group B	Part 1, JM-010 component Group B	Part 1, JM-010 component Group B
Part 2, Placebo Group	Part 2, Placebo Group	Part 2, Placebo Group
Part 1, JM-010 component Group A	Part 1, JM-010 component Group A	Part 1, JM-010 component Group A
Part 1, Placebo Group	Part 1, Placebo Group	Part 1, Placebo Group
Part 1, JM-010 component Group C	Part 1, JM-010 component Group C	Part 1, JM-010 component Group C
Part 2, JM-010 combination Group A	Part 2, JM-010 combination Group A	Part 2, JM-010 combination Group A
Part 2, JM-010 combination Group B	Part 2, JM-010 combination Group B	Part 2, JM-010 combination Group B
Part 2, JM-010 component Group C	Part 2, JM-010 component Group C	Part 2, JM-010 component Group C

Primary Outcome Measures

Name	Time	Method
Unified Dyskinesia Rating Scale (UDysRS)	Week 12	Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia

Secondary Outcome Measures

Name	Time	Method
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Week 12	Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment

Trial Locations

Locations (1)

Bukwang Investigator site; 🇺🇸 Detroit, Michigan, United States