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Efficacy and safety of early intramuscular botulinum toxin injections in the prevention of shoulder deformity in infants with obstetric brachial plexus palsy: a randomized double-blind multicenter controlled trial. POPBTOX
EU CTIS ID: 2024-520391-10-01
What this study is testing
The main aim of this study was to evaluate the efficacy of botulinum toxin injections into the shoulder internal rotator muscles at 12 months of age in preventing worsening of posterior glenohumeral joint subluxation in infants between 11 and 18 months of age, compared with the Sham group (control).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female babies with unilateral POPB.
- More than 10 months and less than 11 months of age.
- Presenting, on the affected side, one of the following 2 risk factors for posterior subluxation of the humeral head: 1/ A limitation of passive joint amplitude in external rotation on the shoulder with respect to the contralateral side of at least 10°. 2/ Active Movement Scale (AMS) score strictly below 6 for external rotation, shoulder abduction, elbow flexion or supination.
- With consent of adult parents.
You likely can't join if
- Bilateral POPB
- Microsurgical management or scheduled secondary muscle surgery between 12 and 18 months of age.
- Non-inclusion related to botulinum toxin use (hypersensitivity to botulinum toxin or excipients, myasthenia).
- Classic contraindications to MRI: pacemaker, metal implantable devices, ocular foreign bodies, etc.
- Impossibility of performing an MRI in a Pediatric Day Hospital, due to contraindications linked to the sedation protocol or organizational constraints.
- Parent(s) unable to give informed consent.
See the full eligibility criteria
- Male or female babies with unilateral POPB.
- More than 10 months and less than 11 months of age.
- Presenting, on the affected side, one of the following 2 risk factors for posterior subluxation of the humeral head: 1/ A limitation of passive joint amplitude in external rotation on the shoulder with respect to the contralateral side of at least 10°. 2/ Active Movement Scale (AMS) score strictly below 6 for external rotation, shoulder abduction, elbow flexion or supination.
- With consent of adult parents.
- Bilateral POPB
- Microsurgical management or scheduled secondary muscle surgery between 12 and 18 months of age.
- Non-inclusion related to botulinum toxin use (hypersensitivity to botulinum toxin or excipients, myasthenia).
- Classic contraindications to MRI: pacemaker, metal implantable devices, ocular foreign bodies, etc.
- Impossibility of performing an MRI in a Pediatric Day Hospital, due to contraindications linked to the sedation protocol or organizational constraints.
- Parent(s) unable to give informed consent.
- Minor parent(s)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.