Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
This study tests a drug called radotinib to see if it is safe and effective for treating Parkinson's disease. Researchers will monitor how well patients tolerate the medication and how their body processes it, while also measuring whether it helps improve Parkinson's symptoms.
Key Objective:The trial is testing whether radotinib can safely improve symptoms and slow the progression of Parkinson's disease.
Who to Consider:People with Parkinson's disease who are interested in trying a new investigational treatment and are willing to participate in detailed safety and effectiveness monitoring should consider enrolling.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease
Eligibility Criteria
Inclusion Criteria: 1. Male and Female from 40 to 80 years old; 2. 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; 3. 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; 4. Hoehn \& Yahr stage ≤ 2.5; 5. Without previous symptomatic treatment for PD disease and with current clinical state not requiring started dopaminergic therapy within 6 months from Baseline; 6. Absence of a parkinsonian syndrome and other neurovascular comorbidities, confirmed by MRI 7. Female subjects must be not of childbearing potential, e.g., documented evidence that they are surgically sterile (e.g., h