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NCT01257828 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)
A Phase 3 study, sponsored by AOSpine North America Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT01257828: Completed Phase 3 study, sponsored by AOSpine North America Research Network.
NCT01257828 is a Phase 3 study that has completed, run by AOSpine North America Research Network. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01257828, a Phase 3 study, has completed, sponsored by AOSpine North America Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological impairment. While surgery is relatively safe, approximately 3% of patients maintain a neurological problem. Given this background and data from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong evidence to consider the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this background, there is a strong basis to consider studying the potential neurological benefits of Riluzole as a treatment to surgical decompression in patients with CSM.
Primary Outcome
The mJOA is a clinician administered scale. It evaluates four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction. The total score ranges from 0 (worst) to 18 (best).
Interventions
- DRUG Placebo medication
- DRUG riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-06-01 |
| Phase | Phase 3 |
What the finished NCT01257828 record still lists
NCT01257828 is an interventional study that assigns participants to a tested intervention. The registered 270 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo medication is the first listed.
NCT01257828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01257828 about?
NCT01257828 is a clinical study titled "Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)". CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological imp...
What is the current status of trial NCT01257828?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2012-03. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT01257828?
The interventions under investigation include: Placebo medication (DRUG), riluzole (DRUG).
Who is sponsoring clinical trial NCT01257828?
This trial is sponsored by AOSpine North America Research Network, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01257828's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 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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