A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Lumbosacral Radiculopathy

Intervention / Treatment
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* Drug: KLS-2031


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below: 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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A group who administered KLS-2031 in the KS-GIG-001-01 Study<br> | Drug: KLS-2031<br>* KLS-2031 administered by transforaminal epidural injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of previous treatment as assessed by frequency and nature of adverse events (AEs) |  | Baseline through end of study (approximately 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156) | 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. | 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) | 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). | 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) | The Galer NPS is a relatively simple, self-administered, 10-item questionnaire for evaluating pain, which assesses distinct pain qualities associated with neuropathic pain. | 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) | 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. | Week 52, Week 104, Week 156 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbosacral Radiculopathy, LSR