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

• JM-010 (Drug)
• Placebo (Drug)

Primary outcomes

• Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS) [7 Days]: Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge

Secondary outcomes

• Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III [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 [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 [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) [28 Days]: Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)

Sex: All, ages: 18 Years to any

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.