Test radotinib to slow progression
- Trial ID
- NCT04691661
- Official Title
- A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease
- Goal
- Test radotinib to slow progression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Il-Yang Pharm. Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- Radotinib HCl 50 mg, Placebo
Plain-Language Summary
They're testing whether radotinib, a cancer drug that blocks the c-Abl tyrosine kinase, can slow early Parkinson's by helping cells clear misfolded proteins like alpha-synuclein and protecting dopamine-producing neurons. Participants take oral radotinib 50 mg or placebo in a randomized, double-blind trial; radotinib is a tyrosine kinase inhibitor thought to boost cellular cleanup and reduce toxic protein-driven cell stress, and because the study enrolls people not yet on dopaminergic therapy, effects together with levodopa are not being assessed here. The trial is looking for adults 40 to 80 with clinically probable Parkinson's diagnosed within three years, a positive DAT scan, Hoehn and Yahr stage 2.5 or less, and who have not started symptomatic dopaminergic treatment.
Locations
- CHRU de Lille - Hôpital Roger Salengro, Lille, France
- CHU Limoges, Limoges, France
- CHU de Lyon HCL, Lyon, France
- Hôpital Nantes-Hotel Dieu, Nantes, France
- Hôpital Pitié-Salpêtrière, Paris, France
- Chu La Miletrie, Poitiers, France
- CHU de Rouen, Rouen, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Radotinib HCl 50 mg. They're testing whether radotinib, a cancer drug that blocks the c-Abl tyrosine kinase, can slow early Parkinson's by helping cells clear misfolded proteins like alpha-synuclein and protecting dopamine-producing neurons. Participants take oral radotinib 50 mg or placebo in a randomized, double-blind trial; radotinib is a tyrosine kinase inhibitor thought to boost cellular cleanup and reduce toxic protein-driven cell stress, and because the study enrolls people not yet on dopaminergic therapy, effects together with levodopa are not being assessed here. The trial is looking for adults 40 to 80 with clinically probable Parkinson's diagnosed within three years, a positive DAT scan, Hoehn and Yahr stage 2.5 or less, and who have not started symptomatic dopaminergic treatment.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 7 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 4 months.