Treatment of Parkinson’s disease (PD)
Conditions
Brief summary
Evaluation of safety parameters (AE, vital signs, 12-lead ECG, laboratory parameters, physical exams).
Detailed description
Pharmacokinetics assessments of Radotinib HCl: Cmax, Tmax, Ctrough, AUCt, AUCinf, AUC0-12h, Kel, t1/2, %AUCextra, Vd/F, CL/F, R., Change from Baseline in the sum of MDS-UPDRS Parts I, II and III after 24 weeks of treatment., Time from baseline to initiation of dopamine-replacement medication., Change in health related quality of life as measured by a quality of life questionnaire (PDQ-39)., Subject's clinical global impression of change.
Interventions
DRUGRadotinib HCl
DRUGPlacebo for Radotinib HCl
Sponsors
Il-Yang Pharm Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety parameters (AE, vital signs, 12-lead ECG, laboratory parameters, physical exams). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics assessments of Radotinib HCl: Cmax, Tmax, Ctrough, AUCt, AUCinf, AUC0-12h, Kel, t1/2, %AUCextra, Vd/F, CL/F, R., Change from Baseline in the sum of MDS-UPDRS Parts I, II and III after 24 weeks of treatment., Time from baseline to initiation of dopamine-replacement medication., Change in health related quality of life as measured by a quality of life questionnaire (PDQ-39)., Subject's clinical global impression of change. | — |
Countries
France
Outcome results
None listed