A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
1 other identifier
observational
5
1 country
1
Brief Summary
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2022
CompletedFirst Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
July 8, 2024
July 1, 2024
4.1 years
October 7, 2022
July 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Baseline through the end of study (approximately 3 years)
Secondary Outcomes (4)
Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)
Week 52, Week 104, Week 156
Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)
Week 52, Week 104, Week 156
Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)
Week 52, Week 104, Week 156
Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)
Week 52, Week 104, Week 156
Interventions
KLS-2031 administered by transforaminal epidural injection
Eligibility Criteria
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.
You may qualify if:
- Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
- Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study
You may not qualify if:
- \. Enrollment in another AAV or other gene therapy trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kolon Investigative Site : CenExel JBR
Salt Lake City, Utah, 84107, United States
Biospecimen
Blood
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Bertoch, MD
JBR Clinical Research
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
November 14, 2022
Study Start
July 26, 2022
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
July 8, 2024
Record last verified: 2024-07