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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Radotinib HCl 50 mg
Drug
Enrolled subject will continue to administer Radotinib 50mg/day, 100mg/day, 150mg/day, 200mg/day, depending on the dose level once daily for 6 months.
Placebo
Drug
Placebo

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Placebo: Dose escalationPlacebo comparator 1 intervention

Group B: Radotinib HCl: Dose escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Evaluation of safety parameters: Adverse Events

Incidence and severity of treatment emergent AEs

Time frame

12 months after dose administration

Secondary outcomes

Pharmacokinetics assessments of Radotinib HCl: Cmax

The maximum (peak) observed drug concentration after dose administration

Time frame

14 days after dose administration

Pharmacokinetics assessments of Radotinib HCl: Tmax

The time to reach maximum (peak) drug concentration after dose administration

Time frame

14 days after dose administration

Pharmacokinetics assessments of Radotinib HCl: Ctrough

Trough plasma concentration (measured concentration at the end of a dosing interval at steady state)

Time frame

14 days after dose administration

Pharmacokinetics assessments of Radotinib HCl: AUCt

Area under the plasma concentration-time curve from time zero to time t

Time frame

14 days after dose administration

Other outcomes

Brain DaT SPECT to measure dopamine neurons and nerve terminals

DaTscan is a specific type of single-photon emission computed tomography (SPECT) imaging technique that helps visualize dopamine transporter in the brain

Time frame

12 months

Concentration of α-synuclein in CSF

Quantification of α-synuclein concentration in CSF

Time frame

6 months

Concentration of Tau and phospho-Tau (p-181) in CSF

Quantification of Tau and phospho-Tau (p-181) concentration in CSF

Time frame

6 months

Concentration of β-amyloid peptide 1-42 in CSF

Quantification of β-amyloid peptide 1-42 concentration in CSF

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Il-Yang Pharm. Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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