Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Parkinson's Disease, Levodopa Induced Dyskinesia (LID)

Intervention / Treatment
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* Drug: JM-010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. History of serotonin syndrome. Breast feeding or pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JM-010<br>JM-010 | Drug: JM-010<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Levodopa Induced Dyskinesia (LID), Dyskinesia