Clinical trial NCT05613569: A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
Official title: A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbosacral Radiculopathy
Keywords: Lumbosacral Radiculopathy
LSR
Lead sponsor: Kolon Life Science
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study

Detailed description: 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.

Eligibility criteria: Inclusion Criteria :

To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:

1. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
2. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study

Exclusion Criteria :

To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:

1. Enrollment in another AAV or other gene therapy trial

Primary outcomes:
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)
Secondary outcomes:
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
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
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
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
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Kolon Investigative Site : CenExel JBR
state: Utah
Study officials:
affiliation: JBR Clinical Research
name: Todd Bertoch, MD
role: PRINCIPAL_INVESTIGATOR
References: