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Active, Not Recruiting

NCT Number: NCT05613569

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lumbosacral Radiculopathy

Sex eligibility

All sexes

Study type

Observational

Primary location

Kolon Investigative Site : CenExel JBR

Salt Lake City, Utah, 84107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Enrollment in another AAV or other gene therapy trial

Treatment and study plan

KLS-2031

Drug

KLS-2031 administered by transforaminal epidural injection

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)

    Time frame: 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.

  2. Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)

    Time frame: 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).

  3. Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)

    Time frame: 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.

  4. Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Kolon Life Science

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2022
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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