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NCT05613569 · ClinicalTrials.gov registry record
A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
A clinical trial of Lumbosacral Radiculopathy, sponsored by Kolon Life Science.
- Active
- Registry status
- 5
- Enrollment target
- 1
- Study location
NCT05613569: Active study of Lumbosacral Radiculopathy, sponsored by Kolon Life Science.
NCT05613569 is a study of Lumbosacral Radiculopathy that is active but no longer recruiting, run by Kolon Life Science. The registered enrollment target is 5 participants, below the 78-participant average among 3 other Lumbosacral Radiculopathy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05613569, a study of Lumbosacral Radiculopathy, is active but no longer recruiting, sponsored by Kolon Life Science.
- ACTIVE NOT RECRUITING
- Registry status
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study
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.
Conditions Studied
Interventions
- DRUG KLS-2031
Study Locations (1)
Utah
- Kolon Investigative Site : CenExel JBR - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2027-04-30 |
What the registry record for NCT05613569 still lists
NCT05613569 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 78-participant average among 3 other Lumbosacral Radiculopathy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Lumbosacral Radiculopathy appearing as the primary indexed condition, and to 1 intervention - of which KLS-2031 is the first listed.
NCT05613569 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05613569 about?
NCT05613569 is a clinical study titled "A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study". This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study
What is the current status of trial NCT05613569?
This trial is currently active not recruiting. The enrollment target is 5 participants. The study started on 2022-07-26. Estimated completion is 2027-04-30.
What conditions does trial NCT05613569 study?
This clinical trial studies the following conditions: Lumbosacral Radiculopathy.
What interventions are being tested in trial NCT05613569?
The interventions under investigation include: KLS-2031 (DRUG).
Who is sponsoring clinical trial NCT05613569?
This trial is sponsored by Kolon Life Science, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05613569 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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