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| Name | Class |
|---|---|
| Contera Pharma ApS | UNKNOWN |
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The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JM-010 | Experimental | JM-010 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JM-010 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS) | Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge | 7 Days |
| Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bloemfontein | South Africa |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires |
| Daily |
| Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale | Subject-rated change in dyskinesia severity as assessed by the CGI scale | 7 Days |
| Safety and Tolerability as measured by assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs) | Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs) | 28 Days |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |