Status:
TERMINATED
Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Dyskinesias
Parkinson Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 eligibili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04377945
Start Date
April 28 2021
End Date
February 14 2024
Last Update
June 17 2024
Active Locations (2)
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1
Bukwang Investigator site
Miami, Florida, United States, 33165
2
Bukwang Investigator site
Detroit, Michigan, United States, 48201