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KLS-2031 for 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
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 moreTrial 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
Todd Bertoch, MDPrincipal InvestigatorJBR Clinical Research
8 Previous Clinical Trials
1,618 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have narrowing in the lower back (lumbar stenosis) that causes pain only when you walk. If your MRI shows narrowing but your pain is not only when walking, you can still participate.You have difficulty accurately identifying and describing your own pain in different parts of your body.You have been experiencing pain for at least 6 months.You have pain in your legs or other parts of your body that is not caused by nerve damage or muscle issues.You have pain that spreads from your spine to other areas, an unstable spine, certain spinal conditions, nerve damage, or severe narrowing of the spinal canal.You have a painful rheumatic disease like fibromyalgia, rheumatoid arthritis, or osteoarthritis that might make it difficult for you to accurately assess your pain during the study.You have nerve pain that is not caused by specific conditions like shingles, diabetes, stroke, infections, or other medical issues.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
- Group 3: Cohort 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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