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

Bukwang Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Parkinson's Disease

Levodopa Induced Dyskinesia (LID)

Treatments

Drug: JM-010

Drug: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02439203

JM-010CS01

Details and patient eligibility

About

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).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.