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Study on the Effectiveness and Safety of NT 201 for Treating Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy

Registered drug

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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 treatment of lower limb spasticity in children and adolescents who have cerebral palsy. Spasticity is a condition where muscles are continuously contracted, which can interfere with movement and speech. The treatment being tested is called NT 201, also known as IncobotulinumtoxinA, which is a type of botulinum toxin used to help relax the muscles. The study aims to determine how effective and safe NT 201 is in treating this condition.

Participants in the study will receive a single injection of NT 201 or a placebo. The study will compare the effects of NT 201 to the placebo over a period of several weeks. The main goal is to see if NT 201 can improve muscle stiffness in the legs of children and adolescents with cerebral palsy between the fourth and sixth week after the injection. The study will also include an open-label extension period, where all participants may receive NT 201, to further assess its long-term effects.

The study is designed to be prospective, meaning it looks forward in time, and randomized, which means participants are randomly assigned to receive either NT 201 or a placebo. It is also double-blind, so neither the participants nor the researchers know who is receiving the actual treatment or the placebo during the initial phase. This helps ensure that the results are unbiased. The study will take place in multiple centers, allowing for a diverse group of participants to be involved.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves children and adolescents aged 2 to 17 years with lower limb spasticity due to cerebral palsy.
Participants must have a specific condition known as bilateral, symmetrical pes equinus.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the severity of the spasticity using the modified Ashworth Scale (MAS).
The MAS score must be at least 2 for both legs to qualify for the study.
Step 3
Treatment administration
Participants receive an intramuscular injection of XEOMIN or a placebo.
The injection is administered once, targeting the affected muscles.
Step 4
Control visits
Control visits are scheduled at week 4 and week 6 after the injection.
During these visits, the MAS score is reassessed to monitor changes in muscle spasticity.
Step 5
Evaluation of results
The primary goal is to observe changes in the MAS score from the baseline at weeks 4 and 6.
Secondary evaluations include the Global Impression of Change Scale for plantar flexors (GICS-PF) and Goal Attainment Scaling (GAS) T-score.
Step 6
Open-label extension period
Participants may enter an open-label extension period if they meet specific criteria, such as a MAS score of at least 1 in both legs.
Continued treatment is subject to agreement by the investigator, parents, and the participant.

Who can join the trial?

7 criteria

Children and teenagers who are between the ages of 2 and 17 years old.
Both boys and girls can participate.
Participants must have a condition called **bilateral, symmetrical pes equinus**. This means both feet point downwards due to **lower limb spasticity** caused by **cerebral palsy**.
Participants can have any level of movement ability, as classified by the **Gross Motor Function Classification System (GMFCS)**.
Participants must have a **Modified Ashworth Scale (MAS)** score of 2 or higher. This score measures muscle tightness in the calf muscles when the foot is in a neutral position and the knee is fully straightened.
For those continuing in the Open-Label Extension Period (OLEX), participants need a MAS score of 1 or higher in both feet.
For the Open-Label Extension Period (OLEX), the investigator, the participant's parents, and the participant (if they are able) must agree to continue the treatment.

Who cannot join the trial?

3 criteria

Children and adolescents who do not have **spasticity** in their lower limbs caused by **cerebral palsy**. **Spasticity** means muscles are too tight and hard to move.
Children younger than 2 years old.
Individuals who are not part of the vulnerable population selected for the study.

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Investigated drugs

NT 201 is a medication being studied for its effectiveness and safety in treating lower limb spasticity in children and adolescents with cerebral palsy. The trial aims to show that NT 201 is more effective than a placebo in reducing muscle stiffness and improving movement in the legs. The study involves a single injection of NT 201, and the results are evaluated between four to six weeks after the injection.

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

What is already known about the treatment

NT 201 – This medication is administered through an injection and is currently being studied in clinical trials for its effectiveness and safety. It is primarily used to treat lower limb spasticity in children and adolescents with cerebral palsy. NT 201 works by blocking nerve signals that cause muscles to contract, helping to reduce muscle stiffness. It is classified as a neuromuscular blocking agent.

Investigated diseases

Cerebral Palsy – Cerebral palsy is a group of disorders that affect a person's ability to move and maintain balance and posture. It is caused by abnormal brain development or damage to the developing brain, often before birth. The condition can lead to muscle stiffness, weakness, and coordination issues. In children, it may result in spasticity, particularly in the lower limbs, which can affect walking and other movements. The severity of symptoms can vary widely among individuals. Over time, the muscle stiffness can lead to joint deformities and difficulties in performing daily activities.