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

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What is this study about?

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.

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

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

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 Study?

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 Study?

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

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Recruiting	20.07.2023

Trial locations

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.

Investigated diseases:

Muscle spasticity

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.

Trial ID:

2024-517668-51-01

Protocol code:

ESPSEVMOLIN2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?