Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorIl-Yang Pharm. Co., Ltd.
About this trial
This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease
Eligibility criteria
Qualifiers
Male and Female from 40 to 80 years old;
Diagnosed with "Clinically Probable Parkinson's Disease" according to the MDS clinical diagnostic criteria, with documented onset of symptoms per treating physician's records within three years of the screening visit;
Positive DAT-scan (e.g. a striatal dopamine transporter deficit on dopamine transporter imaging by DaT-SPECT, characterized by crescent-shaped areas of asymmetrical aspect, or of symmetrical aspect but of uneven intensity, between the right and the left brain hemisphere) confirmed by local reading;
Hoehn & Yahr stage ≤ 2.5;
Disqualifiers
Atypical Parkinsonism or drug-induced Parkinsonism;
Current, or within 60 days of screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD.
Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine, rasagiline) for 30 or more days any time in the past;
Cognitive impairment (MMSE ≤ 24);
Trial design
Treatments tested in this trial
- Radotinib HCl 50 mg
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov