Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
Recruiting
Study on Botulinum Toxin Type A for Preventing Shoulder Deformity in Infants with Brachial Plexus Palsy
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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 a condition known as Obstetrical Brachial Plexus Palsy, which affects infants. This condition can lead to shoulder deformities due to nerve damage that occurs during birth. The study is investigating the use of a treatment called Botulinum Toxin Type A, commonly known as Botox, to prevent these shoulder deformities. Botox is a substance that can help relax muscles and is being tested to see if it can prevent the worsening of shoulder joint issues in affected infants.
The purpose of the study is to evaluate how effective early injections of Botox are in preventing shoulder deformities in infants with this condition. The study involves giving Botox injections to the shoulder muscles of infants at 12 months of age and observing the effects over time. The study will compare the results of infants who receive Botox with those who receive a placebo, which is a substance with no active treatment. The main focus is on preventing the worsening of a specific shoulder joint issue called posterior glenohumeral joint subluxation, which is a partial dislocation of the shoulder joint.
Throughout the study, the infants will be monitored to see how their shoulder joints develop and to assess any changes in their movement abilities. The study will also track any side effects or adverse events that may occur. The goal is to determine if Botox can be a safe and effective treatment option for preventing shoulder deformities in infants with Obstetrical Brachial Plexus Palsy.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Babies, both boys and girls, with a condition called **Obstetrical Brachial Plexus Palsy**. This is a type of injury that affects the nerves in the shoulder area.
- Babies must be older than 10 months but younger than 11 months.
- The affected shoulder must show one of these two signs:
- A reduced ability to rotate the shoulder outward compared to the other shoulder by at least 10 degrees.
- A score below 6 on the **Active Movement Scale (AMS)** for certain movements. The AMS is a way to measure how well a baby can move their arm.
- The baby's parents must give their consent for participation in the study.
Who cannot join the trial?
5 criteria
- Infants who do not have Obstetrical Brachial Plexus Palsy. This is a condition that affects the nerves in the shoulder area, usually occurring during birth.
- Infants who are not between 11 and 18 months of age.
- Infants who have already received treatment with botulinum toxin for their shoulder condition. Botulinum toxin is a substance used to relax muscles.
- Infants with other medical conditions that might interfere with the study.
- Infants whose parents or guardians do not agree to participate in the study.
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Nimes, FranceVerified Centre Hospitalier Universitaire De Rennes
Rennes, France
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Investigated drugs
Botulinum Toxin is used in this trial to help prevent shoulder deformity in infants with a condition called obstetric brachial plexus palsy. The medication is injected into the shoulder muscles to see if it can stop the shoulder joint from moving out of place as the child grows. The goal is to see if these injections can help keep the shoulder joint in a better position and improve movement.
What is already known about the treatment
Botulinum Toxin – This medication is administered through intramuscular injections. It is currently being studied for its effectiveness in preventing shoulder deformity in infants with obstetric brachial plexus palsy. The main therapeutic indication is to prevent the worsening of shoulder joint subluxation in young children. At the molecular level, botulinum toxin works by blocking the release of a neurotransmitter called acetylcholine, which reduces muscle contractions. It is classified as a neuromuscular blocking agent.
Investigated diseases
Obstetrical Brachial Plexus Palsy – This condition occurs when there is an injury to the brachial plexus nerves during childbirth, affecting the shoulder, arm, and hand. It can lead to weakness or paralysis in the affected arm, with varying degrees of severity. As the child grows, the condition may result in limited movement and muscle development in the shoulder and arm. Over time, some children may experience improvement in function, while others may have persistent difficulties. The condition can also lead to joint issues, such as subluxation, where the joint is partially dislocated. Early intervention and therapy are crucial to help improve movement and function in the affected limb.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-520391-10-01Protocol codePOPBTOXEstimated enrolment62 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest
sourced from the EU Clinical Trials Register and site verification
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