Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02145650
Status:
WITHDRAWN
Last Update Posted:
2015-11-03
First Post:
2014-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study suspended due to company decision prior to enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-22', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Assessment of Spasticity Severity using a 5-Point Scale', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of Participants with Spasticity not Receiving Treatment', 'timeFrame': 'Day 1'}, {'measure': 'Spasticity Symptom Assessment Score using a 21-item Questionnaire', 'timeFrame': 'Day 1'}, {'measure': 'Spasticity Impact Assessment Score using a 32-item Questionnaire', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Spasticity Receiving Treatment', 'timeFrame': 'Day 1'}, {'measure': 'Referral Patterns for Spasticity Management', 'timeFrame': 'Day 1'}, {'measure': 'Spasticity Screening Tool Score using a 13-item Questionnaire', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI in clinical practice evaluated for spasticity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI) for a minimum of 3 months\n\nExclusion Criteria:\n\n-Participation in a spasticity clinical trial in the past 5 years.'}, 'identificationModule': {'nctId': 'NCT02145650', 'acronym': 'STRETCh', 'briefTitle': 'Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'EPI-SPAS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI will be evaluated for spasticity by their healthcare provider. Patients diagnosed with spasticity requiring treatment will be enrolled in the study. There is no intervention administered in this study.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'There is no intervention administered in this study.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}