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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    18
  • sponsor
    Kolon Life Science
Updated on 3 March 2022

Summary

Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031

Description

This is a first-in-human, multi-center, double-blind, placebo-controlled, parallel-group, escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031 administered by transforaminal epidural injection to subjects aged 18 to 75 years with neuropathic pain due to Lumbosacral Radiculopathy.

Details
Condition Lumbosacral Radiculopathy
Treatment Placebo, KLS-2031
Clinical Study IdentifierNCT04238793
SponsorKolon Life Science
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

To be eligible for the study, subjects must meet all of the following criteria
at the screening visit
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 may be male or female but must be between the ages of 18 and 75 years, inclusive
The subject must have a body mass index of 35 kg/m2
The subject must have a diagnosis of pain due to LSR
The duration of pain since onset is 6 months

Exclusion Criteria

The subject has
Neuropathic pain due to causes other than that specified in the inclusion criteria (eg, postherpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; spinal abscess, infection, hematoma, spondylolisthesis with displacement, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure)
Radicular pain at more than 1 spinal level, unstable spine, spondylolisthesis (> grade 1), spondylolysis, caudal equina syndrome, arachnoiditis, progressive neurological deficit, moderate to severe central spinal canal stenosis (congenital or acquired) from other origins, vertebral compression fracture(s)
Pain that is associated with a substantial somatic pain component in lower limbs or other parts of the body apart from the back (eg, non-neuropathic/musculoskeletal pain) or more than 1 cause or potential cause for pain symptoms in low limbs
Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or osteoarthritis that in the investigator's opinion would prevent the subject from reliably delineating or assessing his/her pain due to LSR
Note: Any question regarding the acceptability of the etiology of the
neuropathic pain should be discussed with the medical monitor
\. Has lumbar stenosis with pain present solely upon walking. Presence of
lumbar narrowing on MRI is acceptable if the pain is not solely present upon
walking
\. In the investigator's opinion, the subject is unable to reliably delineate
or assess his/her own pain by anatomical location/distribution (eg, the
subject cannot reliably tell the difference between his/her back pain and
lower limb pain and cannot rate the intensity of each separately)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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