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

Phase 2

Completed

• Conditions: Levodopa Induced Dyskinesia (LID); Parkinson's Disease
• Interventions: Drug: JM-010; Drug: Placebo

• Registration Number: NCT02439203
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
JM-010	JM-010	JM-010
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)