18 Participants Needed

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

Recruiting at 1 trial location
KL
Overseen ByKolon Life Science
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Kolon Life Science
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Who Is on the Research Team?

TB

Todd Bertoch, MD

Principal Investigator

JBR Clinical Research

Are You a Good Fit for This Trial?

Inclusion Criteria

The subject must be willing to provide written informed consent for study participation including the 1-year double-blind treatment period and 1-year, open-label, long-term extension period. Informed consent must be obtained before any screening activities are conducted.
The subject must have a body mass index of ≤35 kg/m2.
The subject must have a diagnosis of pain due to LSR.
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Exclusion Criteria

Note: Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the medical monitor.
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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of KLS-2031 or placebo via transforaminal epidural injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks
Multiple visits at Week 1, 2, 4, 12, 26, 52, 78, 104

What Are the Treatments Tested in This Trial?

Interventions

  • KLS-2031
  • Placebo
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Group II: Cohort 2Experimental Treatment2 Interventions
Group III: Cohort 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kolon Life Science

Lead Sponsor

Trials
9
Recruited
3,400+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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