Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-03 @ 7:52 PM
Study NCT ID:
NCT03727100
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Clonidine Micropellet vs Sham-Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain', 'timeFrame': 'Baseline to day 60', 'description': 'Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.'}], 'secondaryOutcomes': [{'measure': 'Change in Oswestry Disability Index (ODI) score', 'timeFrame': 'Baseline to day 30', 'description': '6 categories of 10 question, each question is scored from 0-5 (minimum to maximum). The scores range from 0-100% with lower scores meaning less disability.'}, {'measure': 'Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.', 'timeFrame': '1 day post injection', 'description': 'Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from injection to 24 hrs post injection.'}, {'measure': 'Difference in Rescue medication consumption', 'timeFrame': 'Baseline to day 30', 'description': 'Consumption from baseline through day 30'}, {'measure': 'Percent of subjects with significant improvement in pain', 'timeFrame': 'Baseline to day 30', 'description': '50 percent improvement in pain from baseline to day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lumbosacral Radiculopathy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.\n2. Diagnosis of unilateral radicular leg pain.\n3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.\n4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.\n5. Agrees to follow study-specific medication requirements.\n6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.\n7. Subject must have failed at least one conservative therapy in two different categories.\n\nMain Exclusion Criteria:\n\n1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.\n2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.\n3. Female subjects who are pregnant or breastfeeding.\n4. History of lumbar surgery."}, 'identificationModule': {'nctId': 'NCT03727100', 'acronym': 'RePRIEVE-CM', 'briefTitle': 'Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sollis Therapeutics, Inc.'}, 'officialTitle': 'A Prospective, Multicenter, Randomized, Double-Blinded, Sham-Control Study to Evaluate the Efficacy and Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults', 'orgStudyIdInfo': {'id': 'STX-015-18-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clonidine Micropellets', 'description': 'single dose injection into the lumbar epidural space', 'interventionNames': ['Combination Product: Clonidine Micropellets']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control', 'description': 'non-epidural needle placement', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Clonidine Micropellets', 'type': 'COMBINATION_PRODUCT', 'description': 'Injection', 'armGroupLabels': ['Clonidine Micropellets']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Injection', 'armGroupLabels': ['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': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sollis Clinical Study Site #41', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sollis Clinical Study Site #44', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 29', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'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': '95401', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 28', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'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', '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': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 16', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 15', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'zip': '60657', 'city': 'Shrewsbury', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 17', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 25', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14620', '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', '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': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 22', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77382', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 43', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Sollis Clinical Study Site 20', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'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': '26505', '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'}, 'collaborators': [{'name': 'Lotus Clinical Research, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}