Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI). Rationale and Design of AOSpine Phase III Multi-center Double Blinded Randomized Controlled Trial. (RISCIS)
Bibliographic record
Abstract
Introduction There is convincing evidence from the preclinical realm that the pharmacologic agent riluzole attenuates certain aspects of the secondary injury cascade leading to diminished neurological tissue destruction in animal SCI models. The safety and pharmacokinetic profile of riluzole have been studied in a multicenter pilot study in 36 patients. Efficacy of riluzole in acute human SCI has not been established Material and Methods This ongoing multi-center, international double-blinded phase III RCT will enroll 351 patients with acute C4—C8 SCI and ASIA Impairment Grade A, B or C randomized 1:1 to riluzole and placebo. Primary outcome is the change in ASIA Motor Score (AMS) between baseline and 180 days. Other outcomes include ASIA Upper and Lower Extremity MS; ASIA Sensory Score; ASIA grade; SCIM); SF-36v2; EQ-5D and GRASSP. Two-stage sequential adaptive trial statistical design has 90% power to detect 9 points difference in the ASIA Motor Score at one-sided α = 0.025. Results A matched cohort analysis performed in the Phase I study showed that riluzole treated cervical SCI patients experienced an additional 15.5 points in AMS recovery at 90 days post injury. Although the phase I study was underpowered to investigate efficacy the current phase III study is poised to definitive address this question. Subject enrollment for this trial began on October 1, 2013 in 11 international centers. To date, 31 subjects have been enrolled. Average age of the enrolled subjects is 49 years (SD 16.9); 83.9% males. ASIA at arrival and Pre-Injury status, ASIA Grade A (45%), B (29%), C (26%). GRASSP 54.1 (SD 12.8), SF35v2 PCS 52.6 (SD 9.0) SF36v2 MCS 55.6 (SD 12.8). Conclusion This is a Phase III study of riluzole in acute SCI.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.023 | 0.012 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".