Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT01444794
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2011-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2011-09-27', 'studyFirstSubmitQcDate': '2011-09-29', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).', 'timeFrame': 'Between 1 and 3 months from inclusion', 'description': 'Assessed using the Goal Attainment Scale (GAS).'}], 'secondaryOutcomes': [{'measure': 'Overall attainment of treatment goals', 'timeFrame': 'Between 1 and 3 months from inclusion', 'description': 'Assessed using the GAS T-Score.'}, {'measure': 'The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).', 'timeFrame': 'Up to 5 months'}, {'measure': 'Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).', 'timeFrame': 'Up to 5 months'}, {'measure': 'Global assessment of benefits by both the investigator and the subject (or guardian).', 'timeFrame': 'Up to 5 months', 'description': 'Assessed using a 5-point scale - much worse/worse/unchanged/better/much better'}]}, 'conditionsModule': {'keywords': ['Lower limb spasticity'], 'conditions': ['Spasticity']}, 'descriptionModule': {'briefSummary': 'The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffering from lower limb spasticity following stroke\n* With at least a 12-week interval between the last BoNT-A injection and inclusion\n* Decision already been agreed to inject BoNT-A\n\nExclusion Criteria:\n\n* Documented positive antigenicity to botulinum toxin\n* Any neuromuscular junction indication\n* Severe muscle atrophy in any muscle to be injected\n* Any other indication that might interfere with rehabilitation or the evaluation of results'}, 'identificationModule': {'nctId': 'NCT01444794', 'acronym': 'VALGAS', 'briefTitle': 'Adult Subjects Suffering From Lower Limb Spasticity Following Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke', 'orgStudyIdInfo': {'id': 'A-92-52120-159'}}, 'contactsLocationsModule': {'locations': [{'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Maritimo de Oza', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Mutua de Terrassa', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Vall Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Castellon', 'country': 'Spain', 'facility': 'Hospital de Magdalena', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Gorraiz', 'country': 'Spain', 'facility': 'Hospital de Gorliz', 'geoPoint': {'lat': 42.82125, 'lon': -1.58195}}, {'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Dr. Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Insular', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital De la Fundación Jimenez', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital la Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Morales Meseguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Ntra. Sra. De La Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Valencia al Mar', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Povisa', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Xeral de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}