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Radotinib Dihydrochloride

A new clinical trial is underway to investigate the potential of Radotinib Dihydrochloride in treating Parkinson’s disease. This Phase II study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of Radotinib in patients with Parkinson’s disease. The trial will compare different doses of Radotinib to a placebo over a six-month period, focusing on its effects on motor symptoms, quality of life, and the need for dopamine-replacement medication.

Table of Contents

What is Radotinib Dihydrochloride?

Radotinib Dihydrochloride, also known as Radotinib hydrochloride, is a medication currently being studied for the treatment of Parkinson’s disease (PD)[1]. It is manufactured by IL-YANG PHARM CO. LTD. and is being investigated as a potential new therapy for people with Parkinson’s disease. The drug is administered orally in the form of capsules[1].

Parkinson’s Disease: An Overview

Parkinson’s disease is a progressive neurological disorder that affects movement, balance, and coordination. It occurs when certain nerve cells (neurons) in the brain gradually break down or die. These neurons produce a chemical called dopamine, which helps control movement and coordination. As Parkinson’s disease progresses, the amount of dopamine produced in the brain decreases, causing movement symptoms to worsen over time[1].

Clinical Trial Information

A clinical trial is currently underway to evaluate Radotinib Dihydrochloride as a potential treatment for Parkinson’s disease. This study is a Phase II trial, which means it is designed to assess the drug’s safety, effectiveness, and side effects in a larger group of patients[1]. The trial is described as a “randomized double-blind placebo-controlled multicentre study,” which ensures that the results are as unbiased and reliable as possible.

Key features of the trial include:

  • Testing different doses of Radotinib (50, 100, 150, and 200 mg)
  • Treatment duration of 6 months
  • Comparison with a placebo (an inactive substance)
  • Involvement of multiple research centers

Study Objectives

The clinical trial has several objectives to evaluate Radotinib’s potential as a treatment for Parkinson’s disease[1]:

  1. Primary objective: To assess the safety and tolerability of Radotinib compared to placebo in people with Parkinson’s disease.
  2. Secondary objectives:
    • To study how Radotinib is processed by the body (pharmacokinetics) at different doses.
    • To evaluate the effectiveness of Radotinib in reducing motor symptoms of Parkinson’s disease, as measured by a standardized scale called the MDS-UPDRS.
    • To determine if Radotinib can delay the need for traditional dopamine-replacement medications.
    • To assess the impact of Radotinib on patients’ quality of life.
    • To evaluate the overall clinical improvement as perceived by patients.

Eligibility Criteria

The clinical trial has specific criteria for participants to ensure the safety of the study and the reliability of the results. Some key eligibility criteria include[1]:

  • Age: 40 to 80 years old
  • Diagnosed with “Clinically Probable Parkinson’s disease” within the last three years
  • Positive DAT-scan (a special brain imaging test that helps confirm Parkinson’s disease)
  • Early-stage Parkinson’s disease (Hoehn & Yahr stage ≤ 2.5)
  • No previous treatment for Parkinson’s disease
  • Absence of other neurological conditions that could explain symptoms

There are also several exclusion criteria, such as certain medical conditions, medications, or circumstances that would prevent someone from participating in the study.

Safety and Side Effects

As this is a Phase II clinical trial, one of the main objectives is to evaluate the safety and tolerability of Radotinib Dihydrochloride[1]. The researchers will be closely monitoring for any adverse events (side effects) throughout the study. They will also be tracking vital signs, performing ECGs (heart tests), conducting laboratory tests, and carrying out physical examinations to ensure the safety of the participants.

It’s important to note that as this is an investigational drug, not all potential side effects may be known at this time. Participants in the study will be closely monitored and any adverse events will be promptly addressed.

Potential Benefits

While it’s too early to know for certain, Radotinib Dihydrochloride may offer several potential benefits for people with Parkinson’s disease[1]:

  • Possible improvement in motor symptoms of Parkinson’s disease
  • Potential delay in the need for traditional Parkinson’s medications
  • Possible improvement in quality of life
  • Contribution to the advancement of Parkinson’s disease research

It’s important to remember that as this is a clinical trial, these potential benefits are not guaranteed and more research is needed to confirm the effectiveness of Radotinib in treating Parkinson’s disease.

Aspect Details
Study Type Phase II randomized, double-blind, placebo-controlled, multicenter study
Drug Radotinib Dihydrochloride (IY5511HCl)
Condition Parkinson’s disease
Dosages 50 mg, 100 mg, 150 mg, 200 mg
Administration Oral, daily for 6 months
Primary Endpoint Safety and tolerability evaluation
Key Secondary Endpoints Pharmacokinetics, motor symptom severity, time to dopamine-replacement medication, quality of life
Participant Age Range 40 to 80 years old
Key Inclusion Criteria Recent PD diagnosis, positive DAT-scan, Hoehn & Yahr stage ≤ 2.5
Key Exclusion Criteria Atypical Parkinsonism, cognitive impairment, severe chronic diseases, certain cardiac conditions

FAQ

  • What is the main objective of this clinical trial? The main objective is to evaluate the safety and tolerability of Radotinib (at doses of 50, 100, 150, and 200 mg) when administered for 6 months, compared to a placebo, in subjects with Parkinson's disease.
  • Who can participate in this clinical trial? Participants must be between 40 and 80 years old, diagnosed with 'Clinically Probable Parkinson's disease' within the last three years, have a positive DAT-scan, and meet other specific health criteria. They should not have received previous symptomatic treatment for Parkinson's disease.
  • How long does the trial last? The trial involves a treatment period of 6 months, during which participants will receive either Radotinib or a placebo.
  • What are the secondary objectives of the study? Secondary objectives include evaluating the pharmacokinetics of Radotinib, its effect on motor symptoms severity, the time until dopamine-replacement medication is needed, its impact on quality of life, and the clinical global impression of change.
  • Are there any specific exclusion criteria for the trial? Yes, there are several exclusion criteria. These include having atypical or drug-induced Parkinsonism, cognitive impairment, active psychiatric disorders, severe chronic diseases, and certain cardiac conditions. Participants also cannot be currently using medications for symptomatic treatment of Parkinson's disease.

Ongoing Clinical Trials on Radotinib Dihydrochloride

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Radotinib Dihydrochloride: The investigational drug being studied in this clinical trial for its potential in treating Parkinson's disease.
  • Parkinson's disease (PD): A progressive nervous system disorder that affects movement, often including tremors, stiffness, and loss of balance.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • MDS-UPDRS: Movement Disorder Society-Unified Parkinson's Disease Rating Scale, a comprehensive assessment of motor and non-motor symptoms in Parkinson's disease.
  • DAT-scan: A specialized imaging technique used to detect dopamine deficiency in the brain, often used to diagnose Parkinson's disease.
  • Hoehn & Yahr stage: A scale used to describe the progression of Parkinson's disease symptoms.
  • QTcF: The corrected QT interval on an electrocardiogram, used to assess the heart's electrical activity and potential risks of certain medications.
  • Dopamine-replacement medication: Drugs that aim to increase dopamine levels or mimic its effects in the brain to treat Parkinson's disease symptoms.
  • PDQ-39: Parkinson's Disease Questionnaire-39, a measure used to assess health-related quality of life in Parkinson's disease patients.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-radotinib-for-patients-with-parkinsons-disease/