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Study on Botulinum Toxin Type A for Treating Spastic Equinovarus in First-Time Stroke Patients

Verified siteRegistered drugNo placebo

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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 spastic equinovarus, a condition that can occur in patients who have experienced their first-ever stroke. This condition involves muscle tightness and abnormal positioning of the foot, which can make walking difficult. The treatment being studied is an injection of botulinum toxin type A, known by the brand name Dysport. This treatment is administered as an injection into the muscles of the lower leg.

The purpose of the study is to explore how this treatment affects the muscles, tendons, and nerves in patients with spastic equinovarus after a stroke. The study will use advanced techniques like Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) to observe these changes. These methods help in understanding how the treatment works and in improving future treatment plans for patients with this condition.

Participants in the study will receive the treatment and be monitored over time to see how their condition changes. The study aims to gather information that could help optimize treatment strategies and improve long-term outcomes for people with spastic equinovarus following a stroke. The study will not involve any other medications or treatments, and some participants may receive a placebo for comparison purposes.

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 visit and consent
Upon joining the study, you will attend an initial visit where you will be asked to provide voluntary written informed consent. This means you agree to participate in the study after understanding all the details and potential risks involved.
During this visit, your eligibility will be confirmed based on specific criteria, such as being at least 18 years old, having experienced a first-ever stroke, and having a clinical need for treatment of spastic equinovarus.
Step 2
Treatment administration
You will receive an injection of botulinum toxin type A into the affected muscles of your lower leg. This medication is known as Dysport 500 U and is administered as a solution for injection.
The injection is given directly into the muscle, a method known as intramuscular injection. The frequency and dosage will be determined by the study team based on your specific needs.
Step 3
Follow-up assessments
After the treatment, you will undergo several follow-up assessments to monitor changes in your muscle, tendon, and neural properties. These assessments will use techniques such as Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA).
The primary goal of these assessments is to evaluate the volume of your muscles and the neural contributions to muscle resistance.
Step 4
Ongoing monitoring
Throughout the study, you will be monitored regularly to ensure your safety and to observe the long-term response to the treatment.
You will be required to use highly effective methods of birth control during the study period to prevent pregnancy, as the treatment may pose risks to an unborn child.
Step 5
Study completion
The study is expected to continue until the end of 2026. Upon completion, you will have a final visit to review your progress and any changes observed during the study.
The information gathered from your participation will help in optimizing treatment strategies for future patients with similar conditions.

Who can join the trial?

7 criteria

The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures.
The participant must be at least 18 years old at the time of signing the consent form.
The participant must use highly effective birth control methods. These methods have a very low chance of failure (less than 1% per year) when used correctly. Examples include implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), true sexual abstinence (not having heterosexual intercourse during the trial), or having a partner who has had a vasectomy.
The participant must have pes equinovarus due to spasticity. Pes equinovarus is a condition where the foot points downward and inward.
There must be a clinical need for a BoNT injection in the lower leg. BoNT stands for botulinum neurotoxin-A, a treatment used to reduce muscle stiffness.
If the participant has had a previous BoNT injection in the muscles being studied, it must have been at least 3 months ago.
The participant must have experienced their first-ever stroke, affecting only one side of the body (unilateral).

Who cannot join the trial?

4 criteria

Patients who have not experienced their first-ever stroke.
Patients who do not have a condition called spastic equinovarus, which is a type of muscle tightness and foot position issue that can occur after a stroke.
Patients who are not within the age range specified for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

Botulinum Neurotoxin Type A (BoNT) is a medication used in this clinical trial to treat spastic equinovarus, a condition that can occur after a stroke. This condition involves muscle stiffness and abnormal positioning of the foot. The medication works by temporarily relaxing the muscles, which can help reduce stiffness and improve movement. In this study, the effects of this treatment on muscles, tendons, and nerves are being closely examined to better understand how it can help patients recover after a stroke.

Botulinum Toxin Type A - Haemagglutinin Complex

What is already known about the treatment

Botulinum Neurotoxin Type A (BoNT) – This medication is administered through injections directly into the muscles. It is currently being studied for its effects on muscle, tendon, and nerve properties in stroke patients with a condition called spastic equinovarus, which affects the foot and ankle. The main therapeutic use of BoNT in this context is to reduce muscle stiffness and improve movement. At the molecular level, BoNT works by blocking the release of a chemical called acetylcholine, which is responsible for muscle contraction, thereby relaxing the muscles. It is classified as a neurotoxin and is commonly used in various medical and cosmetic treatments to manage muscle-related conditions.

Investigated diseases

Spastic Equinovarus Deformity – Spastic equinovarus deformity is a condition often seen in stroke patients, characterized by an abnormal positioning of the foot. This condition results from increased muscle tone and spasticity, leading to the foot being pointed downward and inward. The progression involves persistent muscle contractions, which can cause stiffness and difficulty in moving the affected limb. Over time, this can lead to changes in muscle and tendon properties, affecting the overall function of the foot and leg. The condition can impact walking and balance, making mobility challenging for those affected. It is often associated with neurological changes following a stroke, contributing to the altered muscle control.