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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
JM-010
Contera Investigational site_IT
Roma, Italy
Contera Investigational site_ES
Madrid, Spain
Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
Time frame: Baseline to Week 48
Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
Blood pressure in mmHg
Time frame: 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
Time frame: Baseline to Week 48
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
1. 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. 2. 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.
Time frame: Baseline to Week 48
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