Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04446702
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average total dose injected during all sessions of Dysport® in ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Median total dose injected during all sessions of Dysport® in ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Average interval between Dysport® injections in ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}], 'secondaryOutcomes': [{'measure': 'Baseline subjects characteristics', 'timeFrame': 'Baseline (first Dysport® injection)', 'description': '* Demography (age at first injection during the period of interest, sex, weight)\n* History of spasticity'}, {'measure': 'Total number of Dysport® injection cycles', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Total time exposure to Dysport® treatment in ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Total dose injected per cycle, per limb, per muscle and overall', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Number of muscles injected in ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Reported reason for Dysport® injection and for change', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'Outcome will be assessed according following reasons: due to medical need, unplanned need and not recorded'}, {'measure': 'Number of Dysport® interruptions', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)'}, {'measure': 'Reasons of Dysport® discontinuation', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019).', 'description': 'Outcome will be assessed according following reasons: side effects (e.g. excessive weakness, hematoma), contractures, absence of clinical response, long lasting clinical improvement, patient lost follow up and other.'}, {'measure': 'Changes in Modified Ashworth Scale (MAS) scores by time period per muscle', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'The MAS is a six-point scale to grade muscle tone in the injected muscle from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). Upper limb: shoulder abduction, elbow flexion, elbow extension, wrist flexion, wrist extension and fingers flexion. Lower limb: hip flexion, hip adduction, hip abduction, knee flexion, knee extension, ankle dorsiflexion and ankle plantar flexion.'}, {'measure': 'Changes in Functional Independence Measure (FIM) subscales', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'Subscales and total scores of FIM will be measured. The FIM is a method for categorising patients on a seven-point scale (range 1 to 7). It comprises of 18 items, grouped into 2 subscales (motor and cognition). The motor subscale includes: eating, grooming, bathing, dressing upper body, dressing lower body, toileting, bladder management, bowel management, transfers - bed/chair/wheelchair, transfers - toilet, transfers - bath/shower, walk/wheelchair and stairs. The cognition subscale includes: comprehension, expression, social interaction, problem solving and memory. The Scores are summed to obtain a total score that can range between 18 and 126.'}, {'measure': 'Changes in Pain score according to pain Visual Analogue Scales (VAS)', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'The pain Visual Analogue Scale (VAS) is a numeric graphic rating scale (NGRS) of self-reported symptoms. Scores are recorded as whole numbers between zero and 10, where zero indicates no pain symptom at all, and 10 indicates a as bad as it could be.'}, {'measure': 'Gait pattern evaluation in patients with LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'Gait Pattern Modification in patients with LLS is based on physician´s clinical evaluation and it will be evaluated for each lower limb (left and right) or both according to pre-specified patterns: equinismus, foot inversion, knee hyperextension, adduction, mowing abduction, thigh elevation, hip elevation, false trendelenburg, not able to walk. The Gait Pattern Improvement is described based on patient´s perception of gait. The patients respond Yes or No and if Yes the % of improvement is replied'}, {'measure': 'Concomitant drugs for the management of patients with ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'List the systemic drug therapies, including: antispasticity medications (e.g. Baclofen, Tizanidin, Dantrolene), simple pain medications (e.g. paracetamol or NSAIDS), neuropathic pain and spasticity medications (e.g. Gabapentin, Pregabalin, Amitriptyline), opioids, phenol, alcool or other neurolytic agents.'}, {'measure': 'Non-drug concomitant therapies for the management of patients with ULS +/- LLS', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'List the non-drug concomitant therapies, including occupational therapy, physiotherapy and others (e.g.: orthotics, serial casting, splinting, electric stimulation)'}, {'measure': 'Incidence and intensity of Adverse Events', 'timeFrame': 'From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)', 'description': 'Adverse events will be assessed according to incidence, intensity/grade (mild, moderate and severe), causality (related and not related to the product), outcome (the overall association between an exposure to a drug and an outcome) and action taken. All Adverse Events (AEs) (including fatal events and Serious Adverse Events (SAEs)) and special situation (pregnancy, overdose, off-label use) will be reported with the number and proportion of events. The incidence will be provided and classified by System Organ Class and Preferred Term'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spasticity']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible adult patients having received Dysport® for at least three cycles for the treatment of ULS +/- LLS between January 1st, 2006 and July 31st, 2019 at Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil with pre- and post-injection effectiveness data available will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult aged ≥18 years old at the time of the first Dysport® injection\n* Diagnosed with spasticity\n* Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period\n* Follow up effectiveness data are available in the subject's medical record\n\nExclusion Criteria:\n\n* Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study\n* Adults with cerebral palsy\n* Patients treated with BoNT-A in a clinical trial setting"}, 'identificationModule': {'nctId': 'NCT04446702', 'acronym': 'RETURN', 'briefTitle': 'Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)', 'orgStudyIdInfo': {'id': 'A-BR-52120-269'}}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}