Back to resultsSingle Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Primary Purpose
Lumbosacral Radiculopathy
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KLS-2031
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lumbosacral Radiculopathy focused on measuring Lumbosacral Radiculopathy, LSR
Eligibility Criteria
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).
Sites / Locations
- Kolon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
KLS-2031 low dose(1x10^11 VG/DRG) or Placebo
KLS-2031 medium dose(1x10^12 VG/DRG) or Placebo
KLS-2031 high dose(1x10^13 VG/DRG) or Placebo
Outcomes
Primary Outcome Measures
Number of subjects with treatment-related adverse event
Secondary Outcome Measures
Number of subjects with treatment-related adverse event
Number of subjects with treatment-related adverse event by transforaminal epidural injection as measured by the occurrence of injection site reactions
Change from baseline in weekly mean of the average daily pain score
Change from baseline in Galer Neuropathic Pain Scale (Galer NPS)
Number and percentage of subjects who have ≥30% and ≥50% reduction from baseline in the average daily pain score (PI-NRS)
Time (number of weeks) to ≥30% and ≥ 50% reduction from baseline in the average daily pain score (PI-NRS)
Number and percentage of subjects who are much improved or very much improved from baseline
Change from baseline in the modified Modified Roland-Morris Disability Questionnaire (RMDQ) scores (back pain and leg pain)
Amount of rescue medication used (in terms of dosage/day)
Time to treatment failure, defined as the day and time a subject starts pain medication other than acetaminophen for the treatment of neuropathic pain
Change from baseline in the Simple Profile of Moods States (POMS) - 2 Short Form total score and domain scores
Change from baseline in Daily Sleep Interference Scale (DSIS) score
Change from baseline in the Short Form-36 v2 (SF-36v2) score
Assessment of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04238793
Brief Title
Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kolon Life Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy
Keywords
Lumbosacral Radiculopathy, LSR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
KLS-2031 low dose(1x10^11 VG/DRG) or Placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
KLS-2031 medium dose(1x10^12 VG/DRG) or Placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
KLS-2031 high dose(1x10^13 VG/DRG) or Placebo
Intervention Type
Drug
Intervention Name(s)
KLS-2031
Intervention Description
KLS-2031 administered by transforaminal epidural injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline solution administered by transforaminal epidural injection
Primary Outcome Measure Information:
Title
Number of subjects with treatment-related adverse event
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Secondary Outcome Measure Information:
Title
Number of subjects with treatment-related adverse event
Time Frame
Week 78, Week 104
Title
Number of subjects with treatment-related adverse event by transforaminal epidural injection as measured by the occurrence of injection site reactions
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
Title
Change from baseline in weekly mean of the average daily pain score
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Change from baseline in Galer Neuropathic Pain Scale (Galer NPS)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Number and percentage of subjects who have ≥30% and ≥50% reduction from baseline in the average daily pain score (PI-NRS)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Time (number of weeks) to ≥30% and ≥ 50% reduction from baseline in the average daily pain score (PI-NRS)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 103
Title
Number and percentage of subjects who are much improved or very much improved from baseline
Time Frame
Week 12, Week 26, Week 52, Week 104
Title
Change from baseline in the modified Modified Roland-Morris Disability Questionnaire (RMDQ) scores (back pain and leg pain)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Amount of rescue medication used (in terms of dosage/day)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Title
Time to treatment failure, defined as the day and time a subject starts pain medication other than acetaminophen for the treatment of neuropathic pain
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
Title
Change from baseline in the Simple Profile of Moods States (POMS) - 2 Short Form total score and domain scores
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Change from baseline in Daily Sleep Interference Scale (DSIS) score
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Title
Change from baseline in the Short Form-36 v2 (SF-36v2) score
Time Frame
Week 12, Week 26, Week 52, Week 104
Title
Assessment of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame
Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Kolon Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
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Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
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