Lumbosacral RadiculopathyNCT05613569
A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
An observational study of Lumbosacral Radiculopathy, run by Kolon Life Science at 1 site in United States.
Trial summary
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- KLS-2031
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This long-term follow-up study will include up to 12 patients with neuropathic pain from LSR that have completed the KS-GIG-001-01 Study and were randomized to receive KLS-2031.
Who may be able to join
- To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:
- Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
- Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study
Who cannot join
- To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:
- 1. Enrollment in another AAV or other gene therapy trial
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
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study
Read the detailed description
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study (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). Following the end of the Open-label Safety Extension Period of the KS-GIG-001-01 Study (Visit 14), patients will enter the Long-term Follow-up Period. These patients will continue to be monitored for AEs (including AEs of special interest) and serious AEs (SAEs) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- KLS-2031
- Keywords
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.
Measured: Baseline through the end of study (approximately 3 years)
Secondary outcomes (4)
Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)
The PI-NRS is measured on an 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain) that the patient selects to best describe the intensity of pain that they have experienced in the last 24 hours.
Measured: Week 52, Week 104, Week 156
Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)
The DSIS has an 11-point numerical scale that asks the patient to assess how pain has interfered with their sleep during the past 24 hours. Response options range from 0 (does not interfere with sleep) to 10 (completely interferes with sleep).
Measured: Week 52, Week 104, Week 156
Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)
The Galer NPS is a relatively simple, self-administered, 10-item questionnaire for evaluating pain, which assesses distinct pain qualities associated with neuropathic pain.
Measured: Week 52, Week 104, Week 156
Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)
The modified RMDQ is a self-administered, 24-question physical disability measurement tool that evaluates both back and leg pain. Each of the 24 questions is asked 2 times, once with regard to back pain and once with regard to leg pain, for a total of 48 items. Each question requires a "yes" or "no" answer; 1 point is scored for each positive response. The total scores are determined on a scale of 0 to 24 for back pain and on a scale of 0 to 24 for leg pain, with 0 representing "no disability" and 24 representing "extreme disability."
Measured: Week 52, Week 104, Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start26 Jul 2022
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 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
- NCT05613569
- Sponsor's protocol ID
- KLS-2031LSRL001
- Status last verified
- Jul 2024
- First submitted
- 7 Oct 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
- ClinicalTrials.gov ID
- NCT05613569
- Acronym / sponsor ID
- KLS-2031LSRL001
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- Lumbosacral Radiculopathy, LSR
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 14 Nov 2022 (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.
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study
Detailed description
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study (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). Following the end of the Open-label Safety Extension Period of the KS-GIG-001-01 Study (Visit 14), patients will enter the Long-term Follow-up Period. These patients will continue to be monitored for AEs (including AEs of special interest) and serious AEs (SAEs) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This long-term follow-up study will include up to 12 patients with neuropathic pain from LSR that have completed the KS-GIG-001-01 Study and were randomized to receive KLS-2031.
Key inclusion criteria (3 listed)
- To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:
- Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
- Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study
Key exclusion criteria (2 listed)
- To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:
- 1. Enrollment in another AAV or other gene therapy trial
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 | – |
Primary outcome
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.
Time frame: Baseline through the end of study (approximately 3 years)
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.
4 secondary outcomes
Change from baseline to each visit in Pain Intensity Numerical Rating Scale (PI-NRS) score = Result at week n - baseline, (n=52, 104, 156)
Time frame: Week 52, Week 104, Week 156
Change from baseline to each visit in Daily Sleep Interference Scale (DSIS) score = Result at week n - baseline, (n=52, 104, 156)
Time frame: Week 52, Week 104, Week 156
Change from baseline to each visit in Galer Neuropathic Pain Scale (Galer NPS) score = Result at week n - baseline, (n=52, 104, 156)
Time frame: Week 52, Week 104, Week 156
Change from baseline to each visit in modified Roland-Morris Disability Questionnaire (RMDQ) score = Result at week n - baseline, (n=52, 104, 156)
Time frame: Week 52, Week 104, Week 156
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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?
An observational study of 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks. (time frame: Baseline through the end of study (approximately 3 years)). 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 8 Jul 2024.