Not provided
Not provided
Not provided
Not provided
Business reasons
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, JM-010 component Group A | Experimental | Part 1, JM-010 component Group A |
|
| Part 1, JM-010 component Group B | Experimental | Part 1, JM-010 component Group B |
|
| Part 1, JM-010 component Group C | Experimental | Part 1, JM-010 component Group C |
|
| Part 1, Placebo Group | Placebo Comparator | Part 1, Placebo Group |
|
| Part 2, JM-010 combination Group A | Experimental | Part 2, JM-010 combination Group A |
|
| Part 2, JM-010 combination Group B | Experimental | Part 2, JM-010 combination Group B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1, JM-010 component Group A | Drug | JM-010 component Group A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Dyskinesia Rating Scale (UDysRS) | Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment | Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other criteria related to other medical conditions to be referred to the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sooyeon Park | Bukwang Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bukwang Investigator site | Miami | Florida | 33165 | United States | ||
| Bukwang Investigator site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind
|
| Part 2, JM-010 component Group C | Experimental | Part 2, JM-010 component Group C |
|
| Part 2, Placebo Group | Placebo Comparator | Part 2, Placebo Group |
|
| Part 1, JM-010 component Group B |
| Drug |
JM-010 component Group B |
|
| Part 1, JM-010 component Group C | Drug | JM-010 component Group C |
|
| Part 1, Placebo Group | Drug | Placebo Group |
|
| Part 2, JM-010 combination Group A | Drug | JM-010 combination Group A |
|
| Part 2, JM-010 combination Group B | Drug | JM-010 combination Group B |
|
| Part 2, JM-010 component Group C | Drug | JM-010 component Group C |
|
| Part 2, Placebo Group | Drug | Placebo Group |
|
| Detroit |
| Michigan |
| 48201 |
| United States |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided