Riluzole is among the first drugs to show efficacy for treating acute SCI, which impacts an estimated 18,000 people in the United States each year. The U.S. Food and Drug Administration approved the drug in 1995 for the treatment of amyotrophic lateral sclerosis, known as ALS or Lou Gehrig's Disease, with a daily oral dose of one 50-milligram tablet twice a day. The same dosage regimen was used for this phase 2/3 multi-center clinical trial repurposing the drug for SCI patients.
Chow cautions that while the results of this study are positive, further investigation is needed given the small number of participants involved in the trial – 32 patients with head and neck injuries were examined. The acute and progressive nature of traumatic SCI and the complexity of secondary injury alters the pharmacokinetics of therapeutics, namely, how the body processes a drug.
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