Dyskinesias, Parkinson Disease
Conditions
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.
Interventions
DRUGPart 1, JM-010 component Group A
JM-010 component Group A
DRUGPart 1, JM-010 component Group B
JM-010 component Group B
DRUGPart 1, JM-010 component Group C
JM-010 component Group C
DRUGPart 1, Placebo Group
Placebo Group
DRUGPart 2, JM-010 combination Group A
JM-010 combination Group A
DRUGPart 2, JM-010 combination Group B
JM-010 combination Group B
DRUGPart 2, JM-010 component Group C
JM-010 component Group C
DRUGPart 2, Placebo Group
Placebo Group
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Dyskinesia Rating Scale (UDysRS) | Week 12 | Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed