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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
CHU de Nantes – Hôpital Laennec	Nantes	France
Cqnalu Hlaogpjpnly Ef Uikmwlsgcrcav Db Lunouwr	Limoges	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	26.08.2021

Trial locations

Investigated drugs:

Radotinib Dihydrochloride

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.

Investigated diseases:

Parkinson's disease

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.

Trial ID:

2024-516549-37-00

Protocol code:

RT51EP1902

NCT ID:

NCT04691661

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?