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Study of individualized doses of botulinum toxin type A (incobotulinumtoxin) in adults with severe spasticity caused by brain damage

Registered drugNo placebo

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What is this trial about?

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

This study examines the effects of IncobotulinumtoxinA (also known as Botulinum toxin type A) in people with severe spasticity caused by brain damage. Spasticity is a condition that causes muscle stiffness and tightness, making it difficult to move arms and legs normally. The medication is given as an injection into the affected muscles.

The purpose of this research is to evaluate how well IncobotulinumtoxinA works and how safe it is when the dose is customized for each person's specific needs. The study focuses on people who have severe muscle stiffness affecting both their arms and legs. The treatment involves receiving injections of the medication, and patients will be monitored for changes in their muscle stiffness and pain levels.

During the study, participants will receive Xeomin (the brand name for IncobotulinumtoxinA) injections. The effects of the treatment will be checked several times over a period of 12 weeks after the injection. The study will look at improvements in muscle stiffness, pain levels, and ability to perform daily activities. The treatment dose will be adjusted based on each person's specific muscle stiffness patterns.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation and treatment
You will receive an injection of IncobotulinumtoxinA (a type of botulinum toxin) at a dose of 800 units or higher, specifically adjusted to your individual needs
The medication will be administered as an injectable solution to treat severe spasticity (muscle stiffness) in your upper and lower limbs
Your muscle tone will be measured using the Asworth scale, pain level using the VAS scale (0-10), and daily activities performance using the Barthel scale
Step 2
6-week follow-up
After 6 weeks from the injection, your condition will be evaluated again
The evaluation will include measurements of muscle stiffness (Asworth scale)
Your pain levels will be assessed using the VAS scale
Your ability to perform daily activities will be measured using the Barthel scale
Your satisfaction with the treatment will be evaluated
Step 3
12-week follow-up
A final evaluation will be conducted 12 weeks after the injection
The same measurements will be repeated: muscle stiffness, pain levels, and daily activities performance
Any side effects or reactions to the treatment will be documented
Your overall satisfaction with the treatment will be assessed

Who can join the trial?

9 criteria

Must be at least 18 years old
Must have severe spasticity (increased muscle stiffness and tightness) affecting both arms and legs due to brain damage
Must require treatment with IncobotulinumtoxinA (a type of botulinum toxin medication) at a dose of 800 units or higher
Must be willing to sign an informed consent form to participate in the study
Must complete assessments including:
- Pain scale (VAS - Visual Analog Scale)
- Muscle tone measurements (Ashworth scale - measures muscle stiffness)
- Barthel scale (measures ability to perform daily activities)
- Must not have any medical conditions that would prevent treatment with botulinum toxin
- Both men and women may participate

Who cannot join the trial?

14 criteria

Age below 18 years or above 65 years
Pregnancy or breastfeeding
Previous allergic reactions to botulinum toxin treatments
Active infections at the planned injection sites
Presence of fixed contractures (permanent muscle shortening) in the affected limbs
Use of medications that could interact with botulinum toxin within 3 months before the study
Participation in other clinical trials within the last 3 months
Severe medical conditions that could affect safety during the study
History of neuromuscular junction disorders (conditions affecting nerve and muscle connections) such as myasthenia gravis
Current treatment with anticoagulants (blood thinning medications)
Inability to comply with study procedures and follow-up visits
Previous treatment with botulinum toxin in the past 4 months
Severe swallowing difficulties (dysphagia)
Presence of active skin conditions at injection sites

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Investigated drugs

IncobotulinumtoxinA (also known as botulinum toxin type A) is a medication that helps reduce muscle stiffness and spasms. It works by temporarily blocking nerve signals that cause muscles to contract. This medication is injected directly into specific muscles that are affected by spasticity (a condition where muscles become continuously contracted, causing stiffness and tightness). The treatment is customized for each patient based on their individual pattern of muscle spasticity and can be used to treat both upper and lower limbs.

What is already known about the treatment

IncobotulinumtoxinA - A highly purified botulinum toxin type A that is administered through intramuscular injection to treat severe spasticity affecting upper and lower limbs, particularly in patients with brain damage. This medication works by blocking nerve signals to muscles, causing temporary muscle relaxation and reducing abnormal muscle contractions and stiffness. As a neurotoxin-based therapeutic agent, it belongs to the class of muscle relaxants and is particularly valuable in treating patients with individualized dosing needs based on their specific spasticity patterns. The medication has been extensively studied in clinical trials and is recognized in medical literature as an effective treatment option for managing severe spasticity with a well-established safety profile.

Investigated diseases

Brain Damage-Related Spasticity - A condition that develops after injury to the brain, causing muscles to become stiff, tight, and resistant to stretching. The affected muscles remain in a constant state of contraction, leading to reduced movement control and abnormal posture. This condition typically affects muscle groups in both upper and lower limbs, interfering with normal movement patterns and daily activities. The muscle stiffness can vary in severity and may fluctuate throughout the day. Spasticity can develop gradually after the initial brain injury and may affect multiple muscle groups simultaneously.