Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT03776318
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2018-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-up Safety of Clonidine Micropellets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2018-12-01', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Average and Worst NRS from Day 60 post injection to 12 months post injection', 'timeFrame': '10 months from completing Day 60 of the STX-015-18-01 study', 'description': 'Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection'}], 'secondaryOutcomes': [{'measure': 'Incidence of Surgeries', 'timeFrame': '12 months from day of injection', 'description': 'Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.'}, {'measure': 'Incidence of Invasive treatment received', 'timeFrame': '12 months from day of injection', 'description': 'Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01'}, {'measure': 'Number of Prescription medications taken', 'timeFrame': '12 months from day of injection', 'description': 'Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbosacral Radiculopathy']}, 'descriptionModule': {'briefSummary': 'Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.\n* Subjects who were unblinded to their treatment in STX-015-18-01 study.'}, 'identificationModule': {'nctId': 'NCT03776318', 'acronym': 'RePRIEVE-CM-LT', 'briefTitle': 'Long-Term Follow-up Safety of Clonidine Micropellets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sollis Therapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults', 'orgStudyIdInfo': {'id': 'STX-015-18-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Safety Group', 'description': 'STX-015-18-01 Clonidine Micropellet long-term safety follow-up', 'interventionNames': ['Drug: Long-Term Safety Follow-up']}, {'label': 'Sham Control', 'description': 'STX-015-18-01 Sham control long-term safety follow-up', 'interventionNames': ['Drug: Long-Term Safety Follow-up']}], 'interventions': [{'name': 'Long-Term Safety Follow-up', 'type': 'DRUG', 'description': 'STX-015-18-01 long-term safety follow-up', 'armGroupLabels': ['Safety Group', 'Sham Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36605', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 36', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 44', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 40', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 49', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '22205', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 30', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 35', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 38', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '61704', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 12', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 13', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 14', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 37', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 10', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 15', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '07702', 'city': 'Shrewsbury', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 17', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 31', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 18', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 21', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 33', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73013', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 19', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 46', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75240', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 42', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 34', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 47', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 23', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 27', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Christopher Gilligan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sollis Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}