Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-09 @ 3:23 PM
Study NCT ID:
NCT03198702
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000076984', 'term': 'Neonatal Brachial Plexus Palsy'}], 'ancestors': [{'id': 'D020516', 'term': 'Brachial Plexus Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001720', 'term': 'Birth Injuries'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First group or "toxin" group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles.\n\nSecond group or "sham" group:the babies receive the same procedure but no injection.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 'At 18 month age'}], 'secondaryOutcomes': [{'measure': 'compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity', 'timeFrame': 'At 18 month age', 'description': 'With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI'}, {'measure': 'compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function', 'timeFrame': 'At 18 month age', 'description': 'By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment.'}, {'measure': 'confirm good clinical tolerance of BTI treatment', 'timeFrame': 'At 18 month age', 'description': 'By measurement of the number of serious and non-serious adverse events'}, {'measure': 'evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder', 'timeFrame': 'At 18 month age', 'description': '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)'}, {'measure': 'determine if the treatment changes the frequency and type of surgical interventions in the long term', 'timeFrame': 'every years on 2 years old to 10 years old', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy', 'children', 'shoulder deformation', 'obstetrical brachial plexus palsy'], 'conditions': ['Obstetrical Brachial Plexus Palsy']}, 'referencesModule': {'references': [{'pmid': '31575585', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '10 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female babies with unilateral OBPP\n* Age between 10 and 11 months\n* 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)\n* Signature of the consent form by (the) parent(s) over the age of majority\n\nExclusion Criteria:\n\n* Bilateral OBPP\n* Microsurgery or secondary muscle surgery planned between 12 and 18 months of age\n* Contraindications to the use of botulinum toxin\n* Contraindications to MRI\n* MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints\n* Parents inapt to provide consent for the participation of their child\n* Parents under the age of 18 years'}, 'identificationModule': {'nctId': 'NCT03198702', 'acronym': 'POPB-TOX', 'briefTitle': 'Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy', 'orgStudyIdInfo': {'id': 'POPB-TOX RB15.050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toxin group', 'description': 'The babies receive a botulinum toxin type A injection at the age of 12 months', 'interventionNames': ['Drug: Botulinum toxin type A injection']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'The babies receive a simulated injection procedure at the age of 12 months', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Botulinum toxin type A injection', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Toxin group']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'The injection is mimed, the procedure is the same as the botulinum toxin injection.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain BROCHARD, Pr', 'role': 'CONTACT', 'phone': '02 98 22 33 73'}, {'name': 'Chritelle PONS, Dr', 'role': 'CONTACT', 'phone': '02 98 22 33 73'}, {'name': 'Sylvain BROCHARD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christelle PONS, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '54630', 'city': 'Flavigny-sur-Moselle', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jennifer BASTIEN, Dr', 'role': 'CONTACT', 'email': 'jennifer.bastien@ugecam.assurance-maladie.fr', 'phone': '03 54 59 19 33'}, {'name': 'Fanny DALMONT, Dr', 'role': 'CONTACT', 'email': 'fanny.dalmont@ugecam.assurance-maladie.fr', 'phone': '03 54 59 19 50'}, {'name': 'Jennifer BASTIEN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fanny DALMONT, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant', 'geoPoint': {'lat': 48.56567, 'lon': 6.18878}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guy LETELLIER, Dr', 'role': 'CONTACT', 'email': 'g.letellier@esean.fr'}, {'name': 'Guy LETELLIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélanie PORTE, Dr', 'role': 'CONTACT', 'phone': '04 66 68 68 68'}, {'name': 'Mélanie PORTE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe VIOLAS, Dr', 'role': 'CONTACT', 'phone': '02 99 28 43 21'}, {'name': 'Philippe VIOLAS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Helene RAUSCENT, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Floriane COLIN, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Madeleine ASLAN, Dr', 'role': 'CONTACT', 'email': 'madeleine.aslan@chu-st-etienne.fr', 'phone': '04 77 82 80 37'}, {'name': 'Vincent GAUTHERON, Pr', 'role': 'CONTACT', 'email': 'vincent.gautheron@chu-st-etienne.fr', 'phone': '04 77 82 80 00'}, {'name': 'Vincent GAUTHERON, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Madeleine ASLAN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bruno DOHIN, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU St Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '94410', 'city': 'Saint-Maurice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathaly QUINTERO, Dr', 'role': 'CONTACT', 'email': 'n.quintero@hopitaux-st-maurice.fr', 'phone': '01 43 96 63 50'}, {'name': 'Anne-Gaëlle PY, Dr', 'role': 'CONTACT', 'email': 'ag.py@hopitaux-st-maurice.fr'}, {'name': 'Nathaly QUINTERO, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne-Gaëlle PYDr, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katherine SANCHEZ, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital national de saint maurice', 'geoPoint': {'lat': 48.82182, 'lon': 2.42716}}], 'centralContacts': [{'name': 'Sylvain Brochard, Pr', 'role': 'CONTACT', 'email': 'sylvain.brochard@chu-brest.fr', 'phone': '(+33) 02 98 22.33.73'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}