Efficacy and Safety of JM-010 in 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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Levodopa Induced Dyskinesia (LID)
• Intervention / Treatment: Drug: Placebo; Drug: JM-010

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: JM-010	Drug: JM-010

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Collaborators: Contera Pharma ApS

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (ESTIMATE): May 8, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Parkinson Disease; Dyskinesia; Levodopa Induced Dyskinesia (LID)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dyskinesias
• Other Study ID Numbers: JM-010CS01