Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT04265092
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2019-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'at inclusion', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At six weeks', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'At three months', 'description': 'Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).'}], 'secondaryOutcomes': [{'measure': 'Six-Minute Walk Test (6MWT)', 'timeFrame': 'at inclusion, at 6 weeks, at three months', 'description': 'The 6 MWT is a simple test which requires a 30-meter course, calm, indoors, flat, in a rectilinear rectangular corridor. The route is marked every 3 meters with colored marks. The U-turn should be viewed with a cone. The purpose of this test is to walk as much as possible for 6 minutes. The score is between 0 meters for a non-ambulatory person and about 900 meters for a healthy subject.'}, {'measure': 'the Multiple Sclerosis Walking Scale (MSWS-12)', 'timeFrame': 'at inclusion, at 6 weeks, at three months', 'description': 'From the numbers circled against these questions, the healthcare professional can calculate the MSWS-12 score. This is done by adding the numbers you have circled, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.'}, {'measure': 'the Goal Attainment Scale (GAS) score with determination', 'timeFrame': 'at inclusion, at 6 weeks, at three months', 'description': 'In collaboration with the patient, the doctor define a primary and a secondary objectives, with a specific mark for each: -2: worse than before, -1: no change, 0: objective achieved, 1: result better than expected, 2: unexpected result'}, {'measure': 'The Timed Up and Go test (TUG)', 'timeFrame': 'at inclusion, at 6 weeks, at three months', 'description': 'TUG performance is rated on a scale of 1 to 5, where 1 indicates "normal functioning" and 5 indicates "severe abnormal behavior", according to the individual\'s perception of the risk of falling (Podsiadlo \\& Richardson, 1991) . The score consists of the time taken to complete the test, in seconds.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gait', 'Multiple Sclerosis', 'Spasticity', 'Toxin', 'Triceps surae'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).\n\nMethods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty-two MS patients with a mean age of 48.2 +/- 12 years were enrolled in this study, 15 women and 7 men. In 13 patients, the disease had been in a relapsing-remitting mode for 15.2 +/- 12 years, 4 patients had secondary-progressive disease and 5 had primary progressive disease, with a mean EDSS of 4.2 +/- 1.5. Triceps surae spasticity on the Modified Ashworth Scale was 2.4 +/- 0.7.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MS patients aged over 18 years\n* with gait problems related to spasticity of the triceps surae,\n* walking 10 m in less than a minute,\n* with or without technical assistance,\n* with an EDSS of 6.5 or less\n* triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.\n\nExclusion Criteria:\n\n* Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.\n* Intolerance to botulinum toxin;\n* botulinum toxin injection in the previous three months.'}, 'identificationModule': {'nctId': 'NCT04265092', 'acronym': 'GAITOX', 'briefTitle': 'Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Pôle Saint Hélier'}, 'officialTitle': 'Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters', 'orgStudyIdInfo': {'id': 'Pole-sthelier'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Incobotulinum toxin A', 'type': 'DRUG', 'description': 'Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This prospective study is an observational pilot study, which seeks to evaluate the impact of a common treatment, as administered on a daily basis, without any change in the patients usual treatment pathway.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pôle Saint Hélier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}