Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 6:33 PM
Study NCT ID:
NCT05613569
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-11-06', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.', 'timeFrame': 'Baseline through the end of study (approximately 3 years)', 'description': 'Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)', 'timeFrame': 'Week 52, Week 104, Week 156', 'description': 'The PI-NRS is measured on an 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain) that the patient selects to best describe the intensity of pain that they have experienced in the last 24 hours.'}, {'measure': 'Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)', 'timeFrame': 'Week 52, Week 104, Week 156', 'description': 'The DSIS has an 11-point numerical scale that asks the patient to assess how pain has interfered with their sleep during the past 24 hours. Response options range from 0 (does not interfere with sleep) to 10 (completely interferes with sleep).'}, {'measure': 'Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)', 'timeFrame': 'Week 52, Week 104, Week 156', 'description': 'The Galer NPS is a relatively simple, self-administered, 10-item questionnaire for evaluating pain, which assesses distinct pain qualities associated with neuropathic pain.'}, {'measure': 'Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)', 'timeFrame': 'Week 52, Week 104, Week 156', 'description': 'The modified RMDQ is a self-administered, 24-question physical disability measurement tool that evaluates both back and leg pain. Each of the 24 questions is asked 2 times, once with regard to back pain and once with regard to leg pain, for a total of 48 items. Each question requires a "yes" or "no" answer; 1 point is scored for each positive response. The total scores are determined on a scale of 0 to 24 for back pain and on a scale of 0 to 24 for leg pain, with 0 representing "no disability" and 24 representing "extreme disability."'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbosacral Radiculopathy', 'LSR'], 'conditions': ['Lumbosacral Radiculopathy']}, 'descriptionModule': {'briefSummary': 'This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study', 'detailedDescription': 'This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study (A Phase 1/2a, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Therapeutic Activity of Single Ascending Doses of KLS-2031 Administered by Transforaminal Epidural Injection in Patients with Neuropathic Pain from Lumbosacral Radiculopathy). Following the end of the Open-label Safety Extension Period of the KS-GIG-001-01 Study (Visit 14), patients will enter the Long-term Follow-up Period. These patients will continue to be monitored for AEs (including AEs of special interest) and serious AEs (SAEs) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This long-term follow-up study will include up to 12 patients with neuropathic pain from LSR that have completed the KS-GIG-001-01 Study and were randomized to receive KLS-2031.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\nTo be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:\n\n1. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group\n2. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study\n\nExclusion Criteria :\n\nTo be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:\n\n1\\. Enrollment in another AAV or other gene therapy trial'}, 'identificationModule': {'nctId': 'NCT05613569', 'briefTitle': 'A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kolon Life Science'}, 'officialTitle': 'A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study', 'orgStudyIdInfo': {'id': 'KLS-2031LSRL001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'KLS-2031', 'type': 'DRUG', 'description': 'KLS-2031 administered by transforaminal epidural injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Kolon Investigative Site : CenExel JBR', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Todd Bertoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JBR Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kolon Life Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}