July 24, 2024

Clinical Trial Demonstrates Potential of ALS Drug for Acute Spinal Cord Injuries

A groundbreaking clinical trial conducted by a renowned pharmacologist at the University of Houston has shown promising results in using the drug Riluzole to improve functionality for individuals with acute spinal cord injuries (SCI). The study found that if the drug is administered within 12 hours of the injury occurring, it can significantly enhance outcome prospects.

Riluzole was initially approved by the U.S. Food and Drug Administration (FDA) in 1995 for the treatment of amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s Disease. It has since demonstrated efficacy for the treatment of acute SCI, which affects approximately 18,000 individuals in the United States each year. The drug, which is taken orally twice a day in the form of a 50-milligram tablet, was repurposed for the clinical trial involving SCI patients.

The published findings in the Journal of Neurotrauma reflect a phase 2/3 multi-center trial in which 32 patients with head and neck injuries were examined. While the results of this small-scale study are positive, the researchers emphasize the need for further investigation and urge caution in drawing definitive conclusions.

Dr. Chow, the lead investigator, notes the significance of the study in providing proof of concept for the development of SCI treatments. She stresses that although Riluzole can be prescribed off-label for acute SCI in clinical settings, it should not be used by chronic SCI patients until it receives FDA approval for that specific purpose.

The study also highlights the potential impact on future dosing strategies, which could lead to improved patient care and therapeutic outcomes. The complex nature of SCI and its progressive effects on the body’s responses to treatment were considered in the trial. A model was created to capture the drug’s dynamic behavior and patient response, using motor scores in various limb movements to assess functionality.

Furthermore, the study revealed a promising biomarker called phosphorylated neurofilament-heavy subunit (pNF-H), specific to SCI, which helped indicate the drug’s efficacy in reducing neuron cell damage. Patients who received Riluzole showed lower levels of pNF-H, affirming the positive effects of the medication on SCI.

The research team includes experts in different fields, underlining the multidisciplinary approach to the study. The funding for the research was provided by various organizations, including the U.S. Army Medical Research Acquisition Activity, the Christopher & Dana Reeve Foundation, and the Institute for Drug Education and Research.

Overall, this clinical trial showcases the potential of Riluzole as a viable treatment option for acute SCI. While more research is necessary to validate these findings, the study offers hope for improved outcomes and therapeutic interventions in the future.

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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it