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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Unnamed facility
Bloemfontein, South Africa
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
Time frame: 7 Days
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 28 Days
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