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NCT05516992 · ClinicalTrials.gov registry record · Phase 3
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
A Phase 3 study of Lumbar Degenerative Disc Disease, sponsored by Spine BioPharma.
- Active
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
- 20
- Study locations
NCT05516992: Active Phase 3 study of Lumbar Degenerative Disc Disease, sponsored by Spine BioPharma.
NCT05516992 is a Phase 3 study of Lumbar Degenerative Disc Disease that is active but no longer recruiting, run by Spine BioPharma. The registered enrollment target is 417 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05516992, a Phase 3 study of Lumbar Degenerative Disc Disease, is active but no longer recruiting, sponsored by Spine BioPharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.
Primary Outcome
The ODI is a validated, 10-item self-reported instrument assessment of pain-related disability. Possible scores range from 0 (no disability) - 50 (severe disability). Further calculations are applied to reach a percentage score.
Conditions Studied
Interventions
- DRUG SB-01 For Injection
- DRUG Sham Needle
Study Locations (20)
Florida
- Science Connections, LLC - Doral
- Coastal Clinical Research - Jacksonville
- Conquest Research - Orlando
- Conquest Research - Orlando
- Pain Relief Centers - St. Petersburg
- Tampa Pain Relief Center - Tampa
- Florida Pain Relief Group - Tampa
- Conquest Research - Winter Park
California
- Neurovations Research - Napa
- Source Healthcare - Santa Monica
Ohio
- Meta Medical Research Institute - Cincinnati
- META Medical Research Institute - Dayton
Alabama
- Central Alabama Research - Birmingham
Arizona
- Evolve Clinical Research - Phoenix
Georgia
- Vista Clinical Research, LLC - Newnan
Idaho
- Injury Care Research - Boise
Indiana
- The Orthopaedic Research Foundation, Inc (OrthoIndy) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 3 |
What the registry record for NCT05516992 still lists
NCT05516992 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Lumbar Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which SB-01 For Injection is the first listed.
NCT05516992 names 20 study sites across 11 states, led by Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05516992 about?
NCT05516992 is a clinical study titled "Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine". The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to contr...
What is the current status of trial NCT05516992?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2022-08-19. Estimated completion is 2025-08-27.
What conditions does trial NCT05516992 study?
This clinical trial studies the following conditions: Lumbar Degenerative Disc Disease.
What interventions are being tested in trial NCT05516992?
The interventions under investigation include: SB-01 For Injection (DRUG), Sham Needle (DRUG).
Who is sponsoring clinical trial NCT05516992?
This trial is sponsored by Spine BioPharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05516992 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lumbar Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05516992's enrollment target sits among peer trials
417 902nd of 2000 higher than 1,099 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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