Open-Label Extension Study of ASTORIA

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia

Conditions
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Dyskinesias

Intervention / Treatment
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* Drug: JM-010


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is able to read, understand, and provide written, dated informed consent. Subjects will be deemed likely to comply with study protocol and communicate with study personnel about adverse events (AEs) and other clinically important information. Completed study visits per protocol in a previous JM-010CS03 study. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments; Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed; The subject himself/herself wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate. 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 At Screening Visit: the subject scores yes on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to Screening Visit; or At Screening Visit: the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to Screening Visit; or At Baseline Visit: the subject scores yes on items 4 or 5 in the Suicidal Ideation section of the C SSRS with reference to Screening Visit Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br>JM-010 fixed combination drug (Group A) will be administered orally. | Drug: JM-010<br>* JM-010<br>|
| Experimental: Low dose<br>JM-010 fixed combination drug (Group B) will be administered orally. | Drug: JM-010<br>* JM-010<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | To summarize the efficacy of JM-010 in change in clinical progression of PD from Baseline to Week 48 as measured by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) Parts I, Ⅱ, and Ⅲ. To summarize the efficacy of JM-010 in change in dyskinesia from Baseline to Week 48 as measured by the MDS-UPDRS Part IV. The score range is 0-132, where a higher score means more severe motor impairment. | Baseline to Week 48 |