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Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase
Maëva Cotinat1,2, Isabelle Boquet1, Moreno Ursino3,4,5
1Institut de Neurosciences de la Timone (UMR7289), Aix-Marseille Université and CNRS, Marseille, France.
Plos One
|January 20, 2023
Summary
Riluzole shows promise in treating spasticity after spinal cord injury (SCI). This clinical trial investigates its safety and effectiveness in reducing spasticity symptoms in SCI patients.
Area of Science:
- Neuroscience
- Clinical Medicine
- Pharmacology
Background:
- Spasticity is a common and challenging motor disorder following spinal cord injury (SCI).
- Current treatments for SCI-related spasticity are often inadequate.
- Riluzole's known effect on persistent sodium currents suggests a potential therapeutic role in managing spasticity.
Purpose of the Study:
- To evaluate the safety and biological effectiveness of riluzole for spasticity management in adults with chronic traumatic SCI.
- The RILUSCI trial aims to provide a potential new therapeutic option for SCI patients experiencing spasticity.
Main Methods:
- A multicenter, double-blind, placebo-controlled trial involving 90 adult participants with SCI-induced spasticity.
- Participants will receive either a placebo or a determined oral dose of riluzole for two weeks.
- Primary endpoints include improvements in the Modified Ashworth Score (MAS) and Numerical Rating Score (NRS); secondary outcomes assess safety, pharmacokinetics, and impact on spasms, pain, bladder function, and quality of life.
Main Results:
- This section is not yet available as the trial is ongoing.
Conclusions:
- This clinical trial is the first to investigate the safety and efficacy of riluzole for reducing spasticity in patients with chronic SCI.
- Findings from this study could establish riluzole as a viable treatment for spasticity in the SCI population.
