Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-03 @ 9:59 AM
Study NCT ID:
NCT00175604
Status:
WITHDRAWN
Last Update Posted:
2015-05-06
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}, {'id': 'C535425', 'term': 'Congenital torticollis'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not able to recruit any subjects for the study and was closed in February 2008', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be range of motion.', 'timeFrame': 'assessed bi-weekly until treatment is complete'}], 'secondaryOutcomes': [{'measure': 'The secondary outcomes will be length of treatment time and number of required surgeries.', 'timeFrame': 'assessed bi-weekly until treatment is complete'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Botox', 'torticollis', 'Congenital Muscular Torticollis (CMT)'], 'conditions': ['Torticollis']}, 'descriptionModule': {'briefSummary': "The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.", 'detailedDescription': 'The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox. The babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon\n* Initial assessment and initiation of treatment prior to 4 months of age\n* Cervical spine radiograph, no focal bony abnormality\n* Head tilt greater than 5 degrees at 5 months of age\n* Lateral head righting past neutral in upright suspension\n* Restricted neck range of movement in lateral flexion or rotation or both\n* Signed consent form and willingness to participate in the study\n* Compliance with attending bi-weekly follow-up appointments\n\nExclusion Criteria:\n\n* Any other diagnosis affecting tone or muscle function\n* Any condition that would preclude an anesthetic\n* Any vertebral abnormalities identified by radiograph\n* Attending other health practitioners for treatment, i.e., massage therapist, chiropractor\n* Any associated ocular problems as determined by a pediatric ophthalmologist'}, 'identificationModule': {'nctId': 'NCT00175604', 'briefTitle': 'Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)', 'orgStudyIdInfo': {'id': 'C03-0550'}, 'secondaryIdInfos': [{'id': 'W03-0164'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia Children's Hospital, Dept. of Orthopedics", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Stephen Tredwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Stephen Tredwell', 'oldOrganization': 'University of British Columbia'}}}}