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

Lumbosacral Radiculopathy Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05613569
Study type Observational
Source Kolon Life Science
Contact
Status Enrolling by invitation
Phase
Start date July 27, 2022
Completion date April 30, 2027
View Details
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