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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003415-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Bukwang Pharmaceutical | INDUSTRY |
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The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study.
Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study.
Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.
The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JM-010 group A | Experimental | Group A (JM-010 dose fixed combination drug(tablet)) +Placebo 2 |
|
| JM-010 group B | Experimental | Group B (JM-010 8/0.8mg dose fixed combination drug(tablet)) + Placebo 1 |
|
| Placebo | Placebo Comparator | Double-dummy - 2 tablets = Placebo 1 +Placebo 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JM-010 group A | Drug | JM-010 fixed combination drug (Group A) + Placebo 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unified Dyskinesia Rating Scale (UDysRS) | To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 12 in the sum of the items comprising UDysRS. The scoring range is 0-104, and a higher score indicates more severe dyskinesia. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | To compare the efficacy of JM-010 to that of placebo therapy as measured by the sum of the MDS-UPDRS Part III score changes from Baseline to Weeks 2, 4, 8, 12. The score range is 0-132, where a higher score means more severe motor impairment. | 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other criteria related to other medical conditions to be referred to the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Contera Clinical Development | Contera Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contera Investigational site_FR | Toulouse | France | ||||
| Contera Investigational site_DE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31356217 | Derived | McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available. |
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| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Double-blind, double-dummy.
| JM-010 group B | Drug | JM-010 fixed combination drug (Group B) + Placebo 1 |
|
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| Placebos | Drug | Placebo 1 + Placebo 2 |
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| Clinician's Global Impression-Change (CGI-C) score | To compare the efficacy of JM-010 to that of placebo therapy in relation to improvement in clinician-reported PD symptoms as measured by CGI-C score at Week 12. The CGI-C uses the following ratings: 0=not assessed; 1=very much improved; 2=much improved; 3=a little improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. | 12 Weeks |
| Hauser diary | To compare the efficacy of JM-010 to that of placebo therapy as measured by ON time without troublesome dyskinesia changes, OFF time changes, ON time with troublesome dyskinesia changes, Total time with dyskinesia changes from Baseline to Week 2, 4, 8, 12 in Hauser diary | 2 Weeks, 4 Weeks, 8 Weeks, 12 Weeks |
| Unified Dyskinesia Rating Scale (UDysRS) | To compare the efficacy of JM-010 to that of placebo therapy in reducing dyskinesia severity in Parkinson's Disease by evaluating the total score mean change from Baseline to Week 2, 4, 8. The scoring range is 0-104, and a higher score indicates more severe dyskinesia. | 2 Weeks, 4 Weeks, 8 Weeks |
| Rostock |
| Germany |
| Contera Investigational site_IT | Roma | Italy |
| Contera Investigational site_KOR | Seoul | South Korea |
| Contera Investigational site_ES | Madrid | Spain |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |