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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002818-16 | EudraCT Number |
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The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.
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This current open-label extension (OLE) study (JM-010CS-OL) will explore the safety and tolerability of long-term administration of JM-010 of patients who completed 12-week treatment of Phase 2 (JM-010CS03) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental | JM-010 fixed combination drug (Group A) will be administered orally. |
|
| Low dose | Experimental | JM-010 fixed combination drug (Group B) will be administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JM-010 | Drug | JM-010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant ECG abnormalities (Safety and Tolerability) | 12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec | Baseline to Week 48 |
| Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability) | Blood pressure in mmHg | Baseline to Week 48 |
| Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability) | Columbia Suicide Severity Rating Scale (C-SSRS): Score ranges is 0- 50, where a higher score means more severe suicial ideation or behavior | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
The score range is 0-132, where a higher score means more severe motor impairment. |
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Inclusion Criteria:
Exclusion Criteria:
Discontinued study drug in a previous JM-010 Dyskinesia efficacy study due to intolerable or unacceptable AEs considered to be related to JM-010.
Has other psychiatric (not including hallucinations due to side effects of dopamine therapy), neurological or behavioral disorders that in the opinion of the investigator may interfere with the conduct or interpretation of the study, including dementia, or subject who is considered violent.
Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or
Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
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| Name | Affiliation | Role |
|---|---|---|
| Contera Clinical Development | Contera Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contera Investigational site_IT | Roma | Italy | ||||
| Contera Investigational site_ES |
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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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| Baseline to Week 48 |
| Madrid |
| Spain |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |