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 Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05613569
• Other study ID #: KLS-2031LSRL001
• Status: Enrolling by invitation
• Start date: July 27, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: November 2022
• Source: Kolon Life Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8
• Est. completion date: April 30, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Drug:
• KLS-2031
KLS-2031 administered by transforaminal epidural injection

Locations

Country	Name	City	State
United States	Kolon Investigative Site : CenExel JBR	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Kolon Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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