Radotinib HCl 50 mg for Parkinson's (NCT04691661)
New drug to slow Parkinson
- 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
- New drug to slow Parkinson
- 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
The goal is to find out whether the drug radotinib is safe and tolerable for people with Parkinson's and whether it might help slow or prevent Parkinson's-related brain changes. Radotinib, a medicine already approved in Korea for a type of leukemia, blocks a protein called c-Abl and gets into the brain better than similar drugs; in lab and animal studies it reduced the Parkinson's-related protein clumps, protected neurons from damage, and prevented loss of dopamine-producing neurons and movement problems. In the trial, adults will be randomly assigned, without knowing which they get, to take 50 mg of radotinib or a placebo while researchers monitor safety, how the body handles the drug, and any signs of benefit. The study is seeking people aged 40 to 80 with early-stage Parkinson's diagnosed within three years, a positive dopamine imaging scan, and who have not yet started standard Parkinson's medications.
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. The goal is to find out whether the drug radotinib is safe and tolerable for people with Parkinson's and whether it might help slow or prevent Parkinson's-related brain changes. Radotinib, a medicine already approved in Korea for a type of leukemia, blocks a protein called c-Abl and gets into the brain better than similar drugs; in lab and animal studies it reduced the Parkinson's-related protein clumps, protected neurons from damage, and prevented loss of dopamine-producing neurons and movement problems. In the trial, adults will be randomly assigned, without knowing which they get, to take 50 mg of radotinib or a placebo while researchers monitor safety, how the body handles the drug, and any signs of benefit. The study is seeking people aged 40 to 80 with early-stage Parkinson's diagnosed within three years, a positive dopamine imaging scan, and who have not yet started standard Parkinson's medications.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 4 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.