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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
Awards & highlights
Study Summary
This trial will see if KLS-2031 is safe and effective at relieving pain.
Eligible Conditions
- Sciatica
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 4, week 12, week 26, week 52, week 78, week 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Amount of rescue medication used (in terms of dosage/day)
Assessment of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS)
Change from baseline in Daily Sleep Interference Scale (DSIS) score
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
KLS-2031 high dose(1x10^13 VG/DRG) or Placebo
Group II: Cohort 2Experimental Treatment2 Interventions
KLS-2031 medium dose(1x10^12 VG/DRG) or Placebo
Group III: Cohort 1Experimental Treatment2 Interventions
KLS-2031 low dose(1x10^11 VG/DRG) or Placebo
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Who is running the clinical trial?
Kolon Life ScienceLead Sponsor
8 Previous Clinical Trials
3,429 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have narrowing in the lower back (lumbar stenosis) that causes pain only when you walk. If your MRI shows narrowing but your pain is not only when walking, you can still participate.You have difficulty accurately identifying and describing your own pain in different parts of your body.You have been experiencing pain for at least 6 months.You have pain in your legs or other parts of your body that is not caused by nerve damage or muscle issues.You have pain that spreads from your spine to other areas, an unstable spine, certain spinal conditions, nerve damage, or severe narrowing of the spinal canal.You have a painful rheumatic disease like fibromyalgia, rheumatoid arthritis, or osteoarthritis that might make it difficult for you to accurately assess your pain during the study.You have nerve pain that is not caused by specific conditions like shingles, diabetes, stroke, infections, or other medical issues.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
- Group 3: Cohort 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants needed for this clinical trial at present?
"The listing for this trial on clinicaltrials.gov suggests that it is not presently recruiting patients. The study was initially posted on March 10th, 2020 but was last updated on October 5th, 2022. Even though this particular trial has ended patient recruitment, there are many other open trials (213 at the time of writing) which may be a better fit."
Answered by AI
Can people of all ages participate in this particular experiment?
"For this particular clinical trial, only patients aged 18-75 can enroll. There are 8 different trials for individuals under 18 and 193 studies for seniors above the age of 65."
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How can I join this experiment?
"This study is exploring whether the intervention is effective for patients with radiculitis who are between 18-75 years old. Up to 18 people can participate in this trial."
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