Not recruiting

Study of Radotinib safety and effectiveness compared to placebo in people with Parkinson's disease

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Parkinson's disease, a progressive nervous system disorder that affects movement. The research evaluates a medication called Radotinib HCl, which will be tested in different doses ranging from 50 to 200 milligrams against placebo over a period of six months.

The purpose of this research is to determine if Radotinib is safe and well-tolerated by people with Parkinson's disease. The study involves patients who have been diagnosed with Parkinson's disease within the past three years and have not yet started regular treatment for their condition. During the study, participants will receive either Radotinib capsules or placebo capsules to take by mouth.

Throughout the study, doctors will monitor participants' health through various medical examinations. They will track changes in disease symptoms using specialized rating scales, measure the medication levels in the body, and assess overall quality of life. The study will also record how long it takes before participants need to start standard Parkinson's disease medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive either Radotinib capsules or placebo capsules (capsules without active medication) to take by mouth
The dose may be 50 mg, 100 mg, 150 mg, or 200 mg of Radotinib, depending on your assigned group
The treatment continues for 6 months
You will need to take the medication orally as prescribed by your doctor
Step 2
Regular health monitoring
Your health will be monitored through several tests:
Regular checks of vital signs including blood pressure and heart rate
Heart monitoring through ECG (a test that records your heart's electrical activity)
Blood tests to check various health parameters
Physical examinations
Step 3
Assessment of Parkinson's symptoms
Your Parkinson's disease symptoms will be evaluated using a rating scale called MDS-UPDRS
Changes in your symptoms will be monitored over the 24-week treatment period
You will complete a quality of life questionnaire called PDQ-39 to assess how the condition affects your daily life
Step 4
Blood sampling for medication monitoring
Blood samples will be collected to measure how the medication moves through your body
These tests will help determine how your body processes the medication
Step 5
Final evaluation
After 6 months, a final assessment will be conducted to evaluate the overall effects of the treatment
Your overall impression of changes in your condition will be recorded
The study team will determine if you need to start standard Parkinson's disease medication

Who can join the trial?

14 criteria

Age between 40 and 80 years old, both men and women can participate
Must have normal blood pressure and heart rate as determined by the doctor
Normal heart electrical activity test (ECG) as determined by the doctor
Laboratory test results within normal ranges, with some exceptions if approved by the doctor
Must be diagnosed with Parkinson's disease within the last 3 years
Must have a positive brain scan (DAT-scan) showing decreased dopamine function
Must have mild to moderate disease severity (Hoehn & Yahr stage 2.5 or less)
Must not have received any previous treatment for Parkinson's disease and not require dopamine therapy within 6 months
Must have Parkinson's disease as the only cause of symptoms, confirmed by brain imaging (MRI)
Women must either be:
- Past menopause (no periods for at least 12 months)
- Surgically unable to have children
- Using effective birth control methods
- Must have health insurance coverage
- Must be able to understand and sign the informed consent form

Who cannot join the trial?

16 criteria

Age below 18 years or above 65 years
Pregnancy or breastfeeding women
History of deep brain stimulation (a surgical treatment involving implanted electrodes in the brain)
Previous brain surgery
Significant heart disease or recent heart problems
Uncontrolled high blood pressure (hypertension)
Severe liver disease
Severe kidney disease
Active cancer or history of cancer in the past 5 years
Current participation in other clinical trials
Use of investigational drugs within 30 days before the study
History of drug or alcohol abuse within the past year
Severe mental health conditions
Unable to provide informed consent
History of allergic reactions to similar medications
Unstable medical conditions that could interfere with the study

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Et Universitaire De Limoges
Verified
Limoges, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Hospitalier Universitaire De Lille
Verified
Lille, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Radotinib is a medication being studied for the treatment of Parkinson's disease. It is an investigational drug that aims to help people with Parkinson's disease manage their condition. The medication is taken orally and is being tested to understand how safe it is and how well patients tolerate it. The study will also look at how the medication moves through the body and how effective it is in treating Parkinson's disease symptoms.

Radotinib Dihydrochloride

What is already known about the treatment

Radotinib - An investigational medication being studied for the treatment of Parkinson's disease, administered orally in various doses ranging from 50 to 200 mg. This drug is currently undergoing clinical trials to evaluate its safety, tolerability, and effectiveness in patients with Parkinson's disease through a randomized, double-blind, placebo-controlled study design. While the exact molecular mechanism of action in Parkinson's disease is being investigated, Radotinib was originally developed as a tyrosine kinase inhibitor, and researchers are exploring its potential neuroprotective properties in the context of neurodegenerative disorders.

Investigated diseases

Parkinson's disease - A progressive neurological disorder that affects movement control and coordination. The condition develops gradually as brain cells that produce dopamine begin to die or become impaired. Common symptoms include tremors (especially when at rest), muscle stiffness, slow movement, and problems with balance and coordination. People with Parkinson's may also experience changes in speech, reduced facial expressions, and difficulty with fine motor tasks. The disease typically starts on one side of the body and gradually affects both sides over time.