Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-19 @ 12:00 AM
Study NCT ID:
NCT02275312
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Goal Attainment Scale (GAS) score.', 'timeFrame': 'Baseline, 16 months'}], 'secondaryOutcomes': [{'measure': 'Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke', 'timeFrame': 'Baseline, 16 months', 'description': 'Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages'}, {'measure': 'Change in Modified Ashworth Scale (MAS) score.', 'timeFrame': 'Baseline, 16 months'}, {'measure': 'Baseline characteristics of patients', 'timeFrame': 'Baseline', 'description': 'Demographic characteristics'}, {'measure': 'Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.', 'timeFrame': 'From baseline up to 16 months'}, {'measure': 'Change in pain according to Visual Analog Scale (VAS).', 'timeFrame': 'Baseline, 16 months'}, {'measure': 'Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).', 'timeFrame': 'Baseline, 16 months'}, {'measure': 'Comfortable barefoot walking speed, measured with the 10-meter walking speed test.', 'timeFrame': 'Baseline, 16 months'}, {'measure': 'Change on EQ-5D quality of life questionnaire', 'timeFrame': 'Baseline, 16 months'}, {'measure': 'Estimation of use of healthcare resources and costs associated with management of spasticity.', 'timeFrame': 'From baseline up to 16 months'}, {'measure': 'Time interval between injections', 'timeFrame': 'From baseline up to 16 months'}, {'measure': 'Cost per patient', 'timeFrame': 'From baseline up to 16 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spasticity']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post-stroke spasticity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18-80 years.\n* Poststroke limb spasticity.\n* Patients who have suffered a stroke in the previous 6 months.\n* Treatment goal has been previously agreed with the patient or their legal representative.\n* Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.\n* No previous treatment with BoNT-A.\n* Patient is able to follow the protocol.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Neuromuscular disease.\n* Use of drugs that interfere with neuromuscular transmission.\n* Any other condition that could interfere with rehabilitation or evaluation of the results.\n* Diagnosis of spasticity not associated with stroke.\n* Pregnant or nursing mothers.\n* Prior participation in any other study in the 6 months before study entry'}, 'identificationModule': {'nctId': 'NCT02275312', 'acronym': 'ETREAT', 'briefTitle': 'ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'ETREAT: A Prospective Observational Study to Evaluate the Effectiveness of Botulinum Toxin Type A (BoNT-A) Injections in Patients With Post-stroke Upper and/or Lower Limb Spasticity in the Early Stage of Spasticity Development.', 'orgStudyIdInfo': {'id': 'A-92-52120-192'}}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Cadiz', 'country': 'Spain', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Córdoba', 'country': 'Spain', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'country': 'Spain', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huelva', 'country': 'Spain', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'city': 'Lleida', 'country': 'Spain', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'country': 'Spain', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pontevedra', 'country': 'Spain', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Salamanca', 'country': 'Spain', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'San Sebastián', 'country': 'Spain', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'city': 'Santiago', 'country': 'Spain', 'geoPoint': {'lat': 37.9358, 'lon': -4.13866}}, {'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valladolid', 'country': 'Spain', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}