Neuropathic Pain From Lumbosacral RadiculopathyPhase 1/2NCT04238793
Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
A Phase 1/2 study testing KLS-2031 in people with Neuropathic Pain From Lumbosacral Radiculopathy, run by Kolon Life Science at 1 site in United States.
Trial summary
Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain From Lumbosacral Radiculopathy
- What is being tested?
- KLS-2031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2020to 18 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in the study, subjects must have met the following criteria at Visit 1 (Screening,
- Day -56 to Day -15):
- The subject signed a 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 have been obtained before any screening activities are conducted.
- The subject, male or female, must have been between the ages of 18 and 75 years, inclusive.
- The subject must have had a body mass index of ≤35 kg/m².
Show all 23Show fewer
- The subject must have had a diagnosis of pain due to LSR, with all of the following characteristics:
- The subject perceived pain in 1 or both lower limbs at areas that are consistent with the area innervated by the lumbar 4 or 5 or sacral 1 (L4, L5, S1) nerve roots, with or without other sensory symptoms in the affected areas (typically, the pain may have been perceived in the buttock, thigh, calf, leg, foot, or toes). If both limbs were affected, pain had to be asymmetrical (ie, pain worse in 1 limb).
- Pain in the leg radiated to below the knee.
- Pain in the leg was worse during rest and/or at night and not solely present upon walking.
- The history of the pain suggested that the cause of the LSR was due to the injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues (including the intervertebral discs).
- The duration of the pain since onset was ≥6 months.
- Based on clinical history, the intensity of the neuropathic (leg) pain had been stable during the 4-week period before screening (the pain may have fluctuated and may have been worse at night or at rest but was present on most days of the week).
- Pain in the leg (worse affected leg) was worse than pain in the back.
- Exclusion Criteria:Subjects were excluded from the study if 1 or more of the following criteria were applicable:
- The subject had:
- 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, 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 was 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 have prevented 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 was to be discussed with the medical monitor.
- Had lumbar stenosis with pain present solely upon walking. Presence of lumbar narrowing on MRI was acceptable if the pain was not solely present upon walking.
- In the investigator's opinion, the subject was unable to reliably delineate or assess his/her own pain by anatomical location/distribution (eg, the subject could not reliably tell the difference between his/her back pain and lower limb pain and could not rate the intensity of each separately).
- The subject had pain in the lower limbs solely upon walking and not at rest.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kolon Investigative Site : CenExel JBR
Salt Lake City, Utah, 84107
About this study
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
Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031
Read the detailed description
This is a first-in-human (FIH), multicenter, 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 LSR.
- Being tested
- KLS-2031, Placebo
- Keywords
- Neuropathic pain from lumbosacral radiculopathy, Lumbosacral radiculopathy, LSR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLS-2031Drug
KLS-2031 administered by transforaminal epidural injection
PlaceboOther
Normal Saline (0.9%) administered by transforaminal epidural injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo Receives: Drug: KLS-2031; Other: Placebo |
| Cohort 2 | Experimental | Dose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo Receives: Drug: KLS-2031; Other: Placebo |
| Cohort 3 | Experimental | Dose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo Receives: Drug: KLS-2031; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of KLS-2031
Frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12-lead electrocardiograms (ECGs)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Secondary outcomes (14)
Long-term safety and tolerability of KLS-2031
Frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12-lead ECGs
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
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
The occurrence of injection site reactions
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Change from baseline in weekly mean of the average daily pain score
calculated as the average of the subject's last 4 available PI-NRS daily scores in the week before the study visit
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Change from baseline in Galer Neuropathic Pain Scale (Galer NPS)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Number and percentage of subjects who have ≥30% and ≥50% reduction from baseline in the average daily pain score (PI-NRS)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Time (number of weeks) to ≥30% and ≥ 50% reduction from baseline in the average daily pain score (PI-NRS)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Number and percentage of subjects who are much improved or very much improved from baseline
based on the Patient Global Impression of Change (PGIC)
Measured: Week 12, Week 26, Week 52, Week 104
Change from baseline in the modified Modified Roland-Morris Disability Questionnaire (RMDQ) scores (back pain and leg pain)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Amount of rescue medication used (in terms of dosage/day)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Time to treatment failure
, defined as the day and time a subject starts pain medication other than acetaminophen for the treatment of neuropathic pain
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Change from baseline in the Simple Profile of Moods States (POMS) - 2 Short Form total score and domain scores
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Change from baseline in Daily Sleep Interference Scale (DSIS) score
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 104
Change from baseline in the Short Form-36 v2 (SF-36v2) score
Measured: Week 12, Week 26, Week 52, Week 104
Assessment of suicidality
using the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start16 Apr 2020
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain From Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolon Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, MD, Principal investigator, JBR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238793
- Sponsor's protocol ID
- KS-GIG-001-01
- Status last verified
- Jul 2024
- First submitted
- 24 Dec 2019
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04238793
- Acronym / sponsor ID
- KS-GIG-001-01
- Keywords
- Neuropathic pain from lumbosacral radiculopathy, Lumbosacral radiculopathy, LSR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031
Detailed description
This is a first-in-human (FIH), multicenter, 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 LSR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KLS-2031, Other: PlaceboDose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo |
| Cohort 2 | Experimental | Drug: KLS-2031, Other: PlaceboDose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo |
| Cohort 3 | Experimental | Drug: KLS-2031, Other: PlaceboDose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- To participate in the study, subjects must have met the following criteria at Visit 1 (Screening,
- The subject signed a 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 have been obtained before any screening activities are conducted.
- The subject, male or female, must have been between the ages of 18 and 75 years, inclusive.
- The subject must have had a body mass index of ≤35 kg/m².
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLS-2031KLS-2031 administered by transforaminal epidural injection | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboNormal Saline (0.9%) administered by transforaminal epidural injection | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
The safety and tolerability of KLS-2031
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12-lead electrocardiograms (ECGs)
14 secondary outcomes
Long-term safety and tolerability of KLS-2031
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52, Week 78, Week 104
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
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
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
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
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
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 104
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
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
Amount of rescue medication used (in terms of dosage/day)
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Time to treatment failure
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
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
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
Change from baseline in the Short Form-36 v2 (SF-36v2) score
Time frame: Week 12, Week 26, Week 52, Week 104
Assessment of suicidality
Time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
Related trials for Neuropathic Pain From Lumbosacral Radiculopathy
Recruiting
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bertoch, MD principal investigator
JBR Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KLS-2031 in people with Neuropathic Pain From Lumbosacral Radiculopathy, run by Kolon Life Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of KLS-2031 (time frame: Week 1, Week 2, Week 4, Week 12, Week 26, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.