Obstetrical Brachial Plexus PalsyPhase 3POPB-TOXNCT03198702
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
A Phase 3 study testing Botulinum toxin type A injection in people with Obstetrical Brachial Plexus Palsy, run by University Hospital, Brest at 7 sites in France.
Trial summary
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Read more about this study
- Who is it for?
- Ages 10 to 11 months
- Conditions the study is for
- Obstetrical Brachial Plexus Palsy
- What is being tested?
- Botulinum toxin type A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 7 sitesFrance
- Study dates
- 17 May 2018to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female babies with unilateral OBPP
- Age between 10 and 11 months
- Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
- Signature of the consent form by (the) parent(s) over the age of majority
Who cannot join
- Bilateral OBPP
- Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
- Contraindications to the use of botulinum toxin
- Contraindications to MRI
- MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
- Parents inapt to provide consent for the participation of their child
- Parents under the age of 18 years
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHRU Brest
Brest, 29609
Sylvain BROCHARD, Pr, 02 98 22 33 73
Chritelle PONS, Dr, 02 98 22 33 73
- Not yet recruiting
Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant
Flavigny-sur-Moselle, 54630
Jennifer BASTIEN, Dr, 03 54 59 19 33, jennifer.bastien@ugecam.assurance-maladie.fr
Fanny DALMONT, Dr, 03 54 59 19 50, fanny.dalmont@ugecam.assurance-maladie.fr
- Not yet recruiting
ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
Nantes
Guy LETELLIER, Dr, g.letellier@esean.fr
Guy LETELLIER, Dr
- Recruiting
CHU Nîmes
Nîmes, 30029
Mélanie PORTE, Dr, 04 66 68 68 68
Mélanie PORTE, Dr
- Recruiting
CHU Rennes
Rennes, 35033
Philippe VIOLAS, Dr, 02 99 28 43 21
Philippe VIOLAS, Dr
- Not yet recruiting
CHU St Etienne
Saint-Etienne, 42055
Madeleine ASLAN, Dr, 04 77 82 80 37, madeleine.aslan@chu-st-etienne.fr
Vincent GAUTHERON, Pr, 04 77 82 80 00, vincent.gautheron@chu-st-etienne.fr
- Recruiting
Hôpital national de saint maurice
Saint-Maurice, 94410
Nathaly QUINTERO, Dr, 01 43 96 63 50, n.quintero@hopitaux-st-maurice.fr
Anne-Gaëlle PY, Dr, ag.py@hopitaux-st-maurice.fr
About this study
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.
The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.
- Conditions
- Obstetrical Brachial Plexus Palsy
- Being tested
- Botulinum toxin type A injection, Sham
- Keywords
- physiotherapy, children, shoulder deformation, obstetrical brachial plexus palsy
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A injectionDrug
A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle.
ShamOther
The injection is mimed, the procedure is the same as the botulinum toxin injection.
| Study group | Role | What they receive |
|---|---|---|
| Toxin group | Experimental | The babies receive a botulinum toxin type A injection at the age of 12 months Receives: Drug: Botulinum toxin type A injection |
| Sham group | Sham comparator | The babies receive a simulated injection procedure at the age of 12 months Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).
Measured: At 18 month age
Secondary outcomes (5)
compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity
With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI
Measured: At 18 month age
compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function
By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment.
Measured: At 18 month age
confirm good clinical tolerance of BTI treatment
By measurement of the number of serious and non-serious adverse events
Measured: At 18 month age
evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder
Bu measurement of the degree of trophicity, fibrosis and fatty infiltration of the injected muscles (supraspinous, infraspinous, teres minor, subscapularis, teres major, pectoralis major, deltoid and latissimus dorsi)
Measured: At 18 month age
determine if the treatment changes the frequency and type of surgical interventions in the long term
the number and type of surgical interventions undergone by the children in each group will be recorded during routine medical follow-up (as in usual practice) until the child's 10th birthday following unblinding (9 years and 6 months after the BTI).
Measured: every years on 2 years old to 10 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start17 May 2018
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetrical Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles. Second group or "sham" group:the babies receive the same procedure but no injection.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198702
- Sponsor's protocol ID
- POPB-TOX RB15.050
- Acronym
- POPB-TOX
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2017
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901.
PubMed 31575585
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT03198702
- Acronym / sponsor ID
- POPB-TOX / POPB-TOX RB15.050
- Conditions
- Obstetrical Brachial Plexus Palsy
- Keywords
- physiotherapy, children, shoulder deformation, obstetrical brachial plexus palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.
The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles. Second group or "sham" group:the babies receive the same procedure but no injection.
| Arm | Type | Receives |
|---|---|---|
| Toxin group | Experimental | Drug: Botulinum toxin type A injectionThe babies receive a botulinum toxin type A injection at the age of 12 months |
| Sham group | Sham comparator | Other: ShamThe babies receive a simulated injection procedure at the age of 12 months |
Who may qualify
- Ages
- 10 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female babies with unilateral OBPP
- Age between 10 and 11 months
- Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
- Signature of the consent form by (the) parent(s) over the age of majority
Key exclusion criteria (7 listed)
- Bilateral OBPP
- Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
- Contraindications to the use of botulinum toxin
- Contraindications to MRI
- MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A injectionA total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle. | Drug | Toxin group |
| ShamThe injection is mimed, the procedure is the same as the botulinum toxin injection. | Other | Sham group |
Primary outcome
Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).
Time frame: At 18 month age
5 secondary outcomes
compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity
Time frame: At 18 month age
compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function
Time frame: At 18 month age
confirm good clinical tolerance of BTI treatment
Time frame: At 18 month age
evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder
Time frame: At 18 month age
determine if the treatment changes the frequency and type of surgical interventions in the long term
Time frame: every years on 2 years old to 10 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 31575585Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901.
- Individual participant dataSharing planned: No
Related trials for Obstetrical Brachial Plexus Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Not yet recruitingObservational study
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
Osbtetric Brachial Plexus Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A injection in people with Obstetrical Brachial Plexus Palsy, run by University Hospital, Brest at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Brochard, Pr ((+33) 02 98 22.33.73, sylvain.brochard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI). (time frame: At 18 month age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.