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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bukwang Pharmaceutical

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 80 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.