NCT05613569

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Kolon Life Science · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbosacral Radiculopathy

Interventions

Type	Name	Description
DRUG	KLS-2031	KLS-2031 administered by transforaminal epidural injection

Timeline

• Start date: 2022-07-26
• Primary completion: 2026-08-30
• Completion: 2027-04-30
• First posted: 2022-11-14
• Last updated: 2024-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study