Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04649632
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean time to next injection per brand', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}, {'measure': 'Median time to next injection per brand', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}, {'measure': 'Dosing of botulinum toxin-A in daily practice in relation to time to next injection', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}], 'secondaryOutcomes': [{'measure': 'Average cost per year per brand per patient', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}, {'measure': 'Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}, {'measure': 'Time interval between 2 injections of the same brand', 'timeFrame': 'From baseline up to end of data collection (January 2012 up to December 2016)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Post Stroke Spasticity']}, 'descriptionModule': {'briefSummary': 'Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox\n\nExclusion Criteria:\n\n* A patient will be excluded if he has been only treated with Xeomin'}, 'identificationModule': {'nctId': 'NCT04649632', 'acronym': 'Relax', 'briefTitle': 'Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.', 'orgStudyIdInfo': {'id': 'CLIN-52120-450'}}, 'contactsLocationsModule': {'locations': [{'zip': '2132LS', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Ipsen Facility', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}