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NCT01597518 · ClinicalTrials.gov registry record · Phase 2
Riluzole in Spinal Cord Injury Study
A Phase 2 study, sponsored by AOSpine North America Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 193
- Enrollment target
NCT01597518 is a Phase 2 study that was terminated before completion, run by AOSpine North America Research Network. The registered enrollment target is 193 participants.
The verdict
NCT01597518, a Phase 2 study, was terminated before completion, sponsored by AOSpine North America Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 193 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.
Interventions
- DRUG Placebo
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-10-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01597518
The ClinicalTrials.gov registry entry for NCT01597518 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AOSpine North America Research Network, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01597518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01597518 about?
NCT01597518 is a clinical study titled "Riluzole in Spinal Cord Injury Study". The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to ...
What is the current status of trial NCT01597518?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 193 participants. The study started on 2013-10. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT01597518?
The interventions under investigation include: Placebo (DRUG), Riluzole (DRUG).
Who is sponsoring clinical trial NCT01597518?
This trial is sponsored by AOSpine North America Research Network, which has 6 total clinical trials registered on ClinicalTrials.gov.
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