Levodopa Induced Dyskinesia (LID), Parkinson's Disease
Conditions
Keywords
Parkinson Disease, Levodopa Induced Dyskinesia (LID), Dyskinesia
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).
Interventions
DRUGJM-010
DRUGPlacebo
Sponsors
Contera Pharma ApS
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Africa
Outcome results
None listed