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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.