NCT04377945

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Bukwang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyskinesias
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Part 1, JM-010 component Group A	JM-010 component Group A
DRUG	Part 1, JM-010 component Group B	JM-010 component Group B
DRUG	Part 1, JM-010 component Group C	JM-010 component Group C
DRUG	Part 1, Placebo Group	Placebo Group
DRUG	Part 2, JM-010 combination Group A	JM-010 combination Group A
DRUG	Part 2, JM-010 combination Group B	JM-010 combination Group B
DRUG	Part 2, JM-010 component Group C	JM-010 component Group C
DRUG	Part 2, Placebo Group	Placebo Group

Timeline

• Start date: 2021-04-28
• Primary completion: 2024-02-14
• Completion: 2024-02-14
• First posted: 2020-05-07
• Last updated: 2024-06-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study