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Study on Botulinum Toxin Type A for Arm Tremor in Patients with Dystonia

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment for dystonic tremor syndrome, a condition that causes involuntary shaking or trembling of the arms. The treatment being tested is called botulinum toxin type A, which is a muscle relaxant that is injected into the affected muscles to help reduce tremors. The specific product used in this study is known as Dysport 300 E.

The purpose of the study is to explore how different factors, such as clinical characteristics and imaging results, affect the effectiveness of botulinum toxin in treating arm tremors associated with dystonia. Participants in the study will receive injections of the treatment and will be monitored to see how their symptoms change over time. The study will also look at various ways to assess the tremors, including using imaging techniques like magnetic resonance imaging (MRI) to better understand the condition.

Throughout the study, researchers will gather information on how the treatment works for different individuals and what factors might influence its success. This information could help improve treatment strategies for people with dystonic tremor syndrome in the future. The study is expected to continue until 2027, with recruitment starting in late 2024.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a clinical diagnosis of dystonic tremor or tremor associated with dystonia, affecting one or both upper limbs.

    The patient must be at least 18 years old and starting botulinum neurotoxin injections as part of normal clinical practice.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the characteristics of the tremor. This includes clinical, electrophysiological, ultrasonographic, and imaging evaluations.

    The assessment aims to understand the tremor's clinical features, such as jerkiness and dominant tremor pattern, and to measure tremor-related activity in specific brain circuits.

  3. Step 3

    Treatment administration

    The patient will receive an injection of Dysport 300 E, a solution for injection containing botulinum toxin type A - haemagglutinin complex.

    The injection is administered to the affected muscles in the upper limbs to help manage the tremor.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will be conducted to monitor the efficacy of the treatment. These assessments will include clinical evaluations and may involve additional electrophysiological, ultrasonographic, and imaging studies.

    The goal is to explore the associations between the tremor characteristics and the efficacy of the botulinum neurotoxin treatment.

  5. Step 5

    Study completion

    The study is expected to continue until May 31, 2027. During this period, the patient will participate in regular assessments to track the progress and outcomes of the treatment.

    The study aims to provide insights into the factors that determine the efficacy of botulinum toxin for managing arm tremor in dystonia.

Who can join the trial?

4 criteria

  • Have a clinical diagnosis of dystonic tremor or tremor associated with dystonia. This means a doctor has confirmed you have this type of tremor.
  • Experience tremor in one or both of your upper extremities, which refers to your arms or hands.
  • Be starting botulinum neurotoxin injections as part of your regular medical treatment. These are injections used to help manage symptoms.
  • Be at least 18 years old.

Who cannot join the trial?

4 criteria

  • Patients who have a medical condition other than dystonic tremor syndrome. This is a condition that causes involuntary shaking or trembling, usually in the hands or arms.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific criteria set by the study organizers.
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Investigated drugs

Botulinum Toxin is used in this study to treat arm tremor in patients with dystonia. It works by blocking nerve signals to the muscles, which can help reduce muscle contractions and tremors. The study aims to understand how different factors might affect the effectiveness of this treatment in reducing tremors in the upper extremity.

What is already known about the treatment

Botulinum Toxin – This medication is administered through injections directly into the affected muscles. It is currently being studied for its effectiveness in treating dystonic tremor syndrome, particularly in the arms. The main therapeutic indication is to reduce muscle spasms and tremors associated with this condition. At the molecular level, Botulinum Toxin works by blocking the release of a neurotransmitter called acetylcholine, which is responsible for muscle contraction, thereby reducing excessive muscle activity. It is classified as a neuromuscular blocking agent.

Investigated diseases

Dystonic Tremor Syndrome – This condition is characterized by involuntary muscle contractions that cause repetitive or twisting movements, often resulting in a tremor. The tremor typically affects the upper extremities and can vary in intensity and frequency. It is associated with dystonia, a movement disorder that causes muscles to contract uncontrollably. The tremor may be accompanied by a sensory trick, where certain actions or positions temporarily reduce the tremor. The condition can be assessed through clinical evaluations, electrophysiological tests, and imaging techniques to understand its characteristics and progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515970-28-00Protocol code115083Estimated enrolment60 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).