Lumbosacral Radiculopathy
Conditions
Keywords
Lumbosacral Radiculopathy, LSR
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.
Interventions
DRUGKLS-2031
KLS-2031 administered by transforaminal epidural injection
Sponsors
Kolon Life Science
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | 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. | Baseline through the end of study (approximately 3 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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). |
| 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 | The Galer NPS is a relatively simple, self-administered, 10-item questionnaire for evaluating pain, which assesses distinct pain qualities associated with neuropathic pain. |
| 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 | 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. |
Countries
United States
Outcome results
None listed