Excess glutamate can be toxic to nerves. NACTN has already conducted a successful Phase I study of riluzole that evaluated the safety of the drug in 36 patients with acute spinal cord injury. The study demonstrated that the drug is indeed safe and well-tolerated. For more information, visit www. In the Phase l study, levels of riluzole in the blood were measured. It was found that although all 36 subjects were given the same dosage of the drug, some had high levels of riluzole in their blood and others low.
Interventional study clinical trial — studies new tests, treatments, drugs, surgical procedures or devices. Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. In the later phase phase 3 , researchers study whether the treatment works better than the current standard therapy.
They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.
There are also less common very early phase 0 and later phase 4 phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. 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 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 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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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Clinical Trials. Find trials By condition, treatment or drug name Search tips. This article reviews the pharmacology and neuroprotective mechanisms of riluzole, and focuses on existing preclinical evidence, and emerging clinical data in the treatment of SCI.
Trial registration: ClinicalTrials. Abstract Spinal cord injury SCI is a devastating event resulting in permanent loss of neurological function. Publication types Research Support, Non-U. Gov't Research Support, U.
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