Back to Search
Start Over
Rationale, design and critical end points for the Riluzole in Acute Spinal Cord Injury Study (RISCIS): a randomized, double-blinded, placebo-controlled parallel multi-center trial
- Source :
- Spinal Cord
- Publication Year :
- 2015
- Publisher :
- Springer Science and Business Media LLC, 2015.
-
Abstract
- Background: Riluzole is a sodium channel-blocking agent used in treating amyotrophic lateral sclerosis. It has been approved by the U.S. Food and Drug Administration, Canadian and Australian authorities, and in many other countries. A phase I trial of riluzole for acute spinal cord injury (SCI) provided safety and pharmacokinetic data and suggested neuroprotective benefits. A phase IIB/III double-blinded randomized controlled trial (RCT) started in January 2014 (https://clinicaltrials.gov, NCT01597518). This article describes the pathophysiological rationale, preclinical experience and design of the phase IIB/III RCT of Riluzole in Acute Spinal Cord Injury Study (RISCIS). Objectives: The primary objective of the trial is to evaluate the superiority of riluzole, at a dose of 100 mg BID in the first 24 h followed by 50 mg BID for the following 13 days post injury, compared with placebo in improving neurological motor outcomes in patients with C4–C8 level, International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) grade A, B or C acute (within 12 h post injury) SCI. Setting: Acute trauma centers worldwide Methods: A double-blind, multi-center, placebo-controlled RCT will enroll 351 participants randomized 1:1 to riluzole and placebo. The primary end point is the change between 180 days and baseline in ISNCSCI Motor Score. This study has 90% power to detect a change of nine points in ISNCSCI Motor Score at one-sided α=0.025. Results: Currently enrolling in 11 centers. Conclusion: This study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI.
- Subjects :
- Adult
Male
0301 basic medicine
medicine.medical_specialty
Time Factors
Neurology
Adolescent
Placebo
Severity of Illness Index
law.invention
Young Adult
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
Severity of illness
medicine
Humans
Spinal cord injury
Spinal Cord Injuries
Aged
Riluzole
business.industry
General Medicine
Middle Aged
medicine.disease
Clinical trial
Neuroprotective Agents
Treatment Outcome
030104 developmental biology
Anesthesia
Acute Disease
Female
Original Article
Neurology (clinical)
business
Paraplegia
030217 neurology & neurosurgery
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 14765624 and 13624393
- Volume :
- 54
- Database :
- OpenAIRE
- Journal :
- Spinal Cord
- Accession number :
- edsair.doi.dedup.....35c6e6a93fa1e457bc848754424f39a1