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

Lumbosacral Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04238793
• Other study ID #: KS-GIG-001-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 10, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2022
• Source: Kolon Life Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

To be eligible for the study, subjects must meet all of the following criteria at the screening visit:

1. 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.

2. The subject may be male or female but must be between the ages of 18 and 75 years, inclusive.

3. The subject must have a body mass index of =35 kg/m2.

4. The subject must have a diagnosis of pain due to LSR

5. The duration of pain since onset is =6 months.

Exclusion Criteria:

1. The subject has:

1. 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).

2. 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).

3. 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.

4. 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.

2. 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.

3. 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).

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Neuralgia
• Radiculopathy

Intervention

Drug:
• KLS-2031
KLS-2031 administered by transforaminal epidural injection

Other:
• Placebo
Saline solution administered by transforaminal epidural injection

Locations

Country	Name	City	State
United States	Kolon Investigative Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Kolon Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with treatment-related adverse event		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Secondary	Number of subjects with treatment-related adverse event		Week 78, Week 104
Secondary	Number of subjects with treatment-related adverse event by transforaminal epidural injection as measured by the occurrence of injection site reactions		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
Secondary	Change from baseline in weekly mean of the average daily pain score		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Change from baseline in Galer Neuropathic Pain Scale (Galer NPS)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Number and percentage of subjects who have =30% and =50% reduction from baseline in the average daily pain score (PI-NRS)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Time (number of weeks) to =30% and = 50% reduction from baseline in the average daily pain score (PI-NRS)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 103
Secondary	Number and percentage of subjects who are much improved or very much improved from baseline		Week 12, Week 26, Week 52, Week 104
Secondary	Change from baseline in the modified Modified Roland-Morris Disability Questionnaire (RMDQ) scores (back pain and leg pain)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Amount of rescue medication used (in terms of dosage/day)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Secondary	Time to treatment failure, defined as the day and time a subject starts pain medication other than acetaminophen for the treatment of neuropathic pain		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
Secondary	Change from baseline in the Simple Profile of Moods States (POMS) - 2 Short Form total score and domain scores		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Change from baseline in Daily Sleep Interference Scale (DSIS) score		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Secondary	Change from baseline in the Short Form-36 v2 (SF-36v2) score		Week 12, Week 26, Week 52, Week 104
Secondary	Assessment of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS)		Week 1, Week 2, Week 4, Week 12, Week 26, Week 52