← Back to Search

Unknown

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Phase 1 & 2
Waitlist Available
Led By Todd Bertoch, MD
Research Sponsored by Kolon Life Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104

Summary

This trial tests a new drug, KLS-2031, on adults with lower back nerve pain. The drug is injected into the spine to see if it can safely reduce pain by targeting the nerves directly.

Eligible Conditions
  • Lumbosacral Radiculopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The safety and tolerability of KLS-2031
Secondary study objectives
Assessment of suicidality
Change from baseline in weekly mean of the average daily pain score
Local safety and tolerability (including AEs, clinical laboratory parameters, and physical examination) of administration by transforaminal epidural injectionepidural injection as measured by the occurrence of injection site reactions
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Dose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo
Group II: Cohort 2Experimental Treatment2 Interventions
Dose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo
Group III: Cohort 1Experimental Treatment2 Interventions
Dose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KLS-2031
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Kolon Life ScienceLead Sponsor
8 Previous Clinical Trials
3,426 Total Patients Enrolled
1 Trials studying Lumbosacral Radiculopathy
5 Patients Enrolled for Lumbosacral Radiculopathy
Todd Bertoch, MDPrincipal InvestigatorJBR Clinical Research
8 Previous Clinical Trials
1,618 Total Patients Enrolled
1 Trials studying Lumbosacral Radiculopathy
5 Patients Enrolled for Lumbosacral Radiculopathy

Media Library

KLS-2031 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04238793 — Phase 1 & 2
Lumbosacral Radiculopathy Research Study Groups: Cohort 2, Cohort 1, Cohort 3
Lumbosacral Radiculopathy Clinical Trial 2023: KLS-2031 Highlights & Side Effects. Trial Name: NCT04238793 — Phase 1 & 2
KLS-2031 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04238793 — Phase 1 & 2
~3 spots leftby Dec 2025