Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia (LID)
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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).
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 7 Days ]
Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge
Secondary Outcome Measures :
Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: 7 Days ]
Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge
Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires [ Time Frame: Daily ]
Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires
Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale [ Time Frame: 7 Days ]
Subject-rated change in dyskinesia severity as assessed by the CGI scale
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) [ Time Frame: 28 Days ]
Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent.
Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.
All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.
Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.
Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).
Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.
History of any other brain surgery or surgery for the treatment of PD.
Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).
A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.
Clinically significant abnormal laboratory data at screening.
Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP1.
History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.