Study on the Safety and Effectiveness of IncobotulinumtoxinA for Treating Limb Spasticity in Children with Cerebral Palsy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for children with cerebral palsy, a condition that affects movement and muscle tone. The treatment being tested is called IncobotulinumtoxinA, also known as XEOMIN. This medication is a type of botulinum toxin that is injected into the muscles to help reduce spasticity, which is the stiffness or tightness of muscles that can occur in cerebral palsy.

The purpose of the study is to investigate how effective and safe IncobotulinumtoxinA is for treating spasticity in both the upper and lower limbs of children with cerebral palsy. The study will involve a dose titration approach, which means adjusting the dose of the medication to find the most effective amount for each child. The study will take place over three injection cycles, with observation periods lasting between 12 to 20 weeks after each injection. The total duration of the study for each participant can be up to 60 weeks.

During the study, children will receive injections of IncobotulinumtoxinA and will be monitored for changes in muscle stiffness and overall movement ability. The study will also track any side effects or adverse events to ensure the safety of the treatment. The goal is to determine if this treatment can help improve the quality of life for children with cerebral palsy by reducing muscle spasticity and improving their ability to move.

1 joining the study

Upon joining the study, the patient will be assessed to ensure they meet the necessary criteria. This includes being between the ages of 2 and 17, having spasticity in the upper and lower limbs due to cerebral palsy, and meeting specific motor function and spasticity scores.

The patient’s parent or legal guardian must provide informed consent for participation in the study.

2 initial assessment

The patient will undergo an initial assessment to evaluate their current condition. This includes measuring spasticity using the Ashworth scale and other relevant scales.

The healthcare professional will determine the appropriate dose of IncobotulinumtoxinA needed, up to a maximum of 22 units per kilogram of body weight, not exceeding 550 units in total.

3 first injection cycle

The patient will receive the first injection of IncobotulinumtoxinA into the muscles, administered through an intramuscular injection. The exact dosage will be based on the initial assessment.

After the injection, the patient will be observed for a period of 12 to 20 weeks to monitor the effects and any potential side effects.

4 follow-up assessments

During the observation period, the patient will have regular follow-up assessments to evaluate changes in spasticity and overall condition.

These assessments will include measurements using the Ashworth scale, Resistance to Passive Movement Scale, and other relevant scales.

5 second injection cycle

If deemed necessary, the patient will receive a second injection of IncobotulinumtoxinA following the same procedure as the first cycle.

The observation period of 12 to 20 weeks will be repeated to monitor the patient’s response to the treatment.

6 third injection cycle

A third injection cycle may be administered if required, following the same process as previous cycles.

The patient will continue to be monitored for changes in their condition and any side effects during the observation period.

7 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall efficacy and safety of the treatment.

The patient’s progress will be measured using the same scales and criteria as in previous assessments.

Who Can Join the Study?

Children (female or male) aged 2 to 17 years
Patients with upper and lower limb spasticity due to cerebral palsy
Gross Motor Function Classification System (GMFCS) from Level II to Level V (a scale that measures movement abilities)
Selected target clinical pattern diagnosed by a qualified health care professional
Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associated with the selected target clinical pattern (a scale that measures muscle stiffness)
Patient deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period
In the case of children pretreated with BoNT-A, time from last injection at least 5 months (BoNT-A is a type of treatment for muscle stiffness)
Informed consent signed by parents or legal guardian

Who Cannot Join the Study?

Patients who have a history of allergic reactions to IncobotulinumtoxinA or any of its ingredients cannot participate. IncobotulinumtoxinA is a type of medication used in this study.
Patients with any other medical condition that might interfere with the study results or pose a risk to the patient cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have received any other botulinum toxin treatment within the last 12 weeks cannot participate. Botulinum toxin is a substance used to treat muscle stiffness.
Patients with a history of muscle weakness or nerve disorders that are not related to cerebral palsy cannot participate. Cerebral palsy is a condition that affects movement and muscle tone.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend scheduled visits cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universita’ Degli Studi Di Verona	Verona	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	10.02.2023

Trial locations

Investigated drugs:

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

IncobotulinumtoxinA is a medication used in this clinical trial to help manage muscle stiffness in children with cerebral palsy. This condition, known as spasticity, affects the muscles in the arms and legs, making them tight and difficult to move. IncobotulinumtoxinA works by relaxing these muscles, which can help improve movement and reduce discomfort. The trial aims to find out how effective and safe this medication is when given in different amounts over a period of time. The study involves children who have either never been treated with this type of medication before or have been treated with similar medications in the past. The goal is to see how well the medication works and how it can be best used to help children with this condition.

Investigated diseases:

Muscle spasticity

Cerebral Palsy – Cerebral Palsy is a group of disorders that affect movement and muscle tone or posture. It is caused by damage that occurs to the immature brain as it develops, most often before birth. The condition results in impaired movement associated with exaggerated reflexes, floppiness or spasticity of the limbs and trunk, unusual posture, involuntary movements, unsteady walking, or some combination of these. People with cerebral palsy may have problems swallowing and commonly have eye muscle imbalance, in which the eyes don’t focus on the same object. They also might suffer from reduced range of motion at various joints of their bodies due to muscle stiffness. The effects of cerebral palsy on functional abilities vary greatly.

Trial ID:

2024-518447-38-00

Protocol code:

INCIPIT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of IncobotulinumtoxinA for Treating Limb Spasticity in Children with Cerebral Palsy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?