Back to resultsEfficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia (LID)
Primary Purpose
Parkinson's Disease, Levodopa Induced Dyskinesia (LID)
Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
JM-010
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson Disease, Levodopa Induced Dyskinesia (LID), Dyskinesia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JM-010
Placebo
Arm Description
JM-010
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires
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
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)
Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)
Full Information
NCT ID
NCT02439203
First Posted
April 30, 2015
Last Updated
January 11, 2016
Sponsor
Bukwang Pharmaceutical
Collaborators
Contera Pharma ApS
1. Study Identification
Unique Protocol Identification Number
NCT02439203
Brief Title
Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia
Acronym
LID
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical
Collaborators
Contera Pharma ApS
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Levodopa Induced Dyskinesia (LID)
Keywords
Parkinson Disease, Levodopa Induced Dyskinesia (LID), Dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JM-010
Arm Type
Experimental
Arm Description
JM-010
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
JM-010
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)
Description
Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Description
Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge
Time Frame
7 Days
Title
Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires
Description
Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires
Time Frame
Daily
Title
Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale
Description
Subject-rated change in dyskinesia severity as assessed by the CGI scale
Time Frame
7 Days
Title
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)
Description
Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Bloemfontein
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia
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