Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial

PLoS ONE, 2023 · DOI: https://doi.org/10.1371/journal.pone.0276892 · Published: January 20, 2023

Spinal Cord Injury Pharmacology Neurology

Simple Explanation

Spasticity, a common motor disorder after spinal cord injury (SCI), often lacks satisfactory treatment. Riluzole, which can reduce persistent sodium current, may help relieve spasticity in SCI patients. The RILUSCI trial aims to determine if riluzole is a safe and effective treatment for spasticity in adults with chronic traumatic SCI. This study involves a double-blind trial where participants will receive either riluzole or a placebo for two weeks. The trial will assess improvements in spasticity using the Modified Ashworth Score (MAS) or the Numerical Rating Score (NRS). Secondary outcomes include assessing safety, riluzole pharmacokinetics, muscle spasms, pain, bladder dysfunction, and quality of life.

Study Duration

36 months (recruitment period)

Participants

Target enrollment: 90 participants, adults aged 18–65 years with spasticity after SCI

Evidence Level

Level 1b-2b, Adaptive multicenter randomized controlled trial

Key Findings

1
This clinical trial will be the first to document the safety and efficacy of riluzole as a means of reducing spasticity in patients with chronic SCI.
2
The primary objectives of the trial will be to define the minimal effective dose of riluzole for treating spasticity, and to assess how effective it is as a means of reducing spasticity.
3
The trial involves a phase 1b to determine the minimal effective dose (MED) of riluzole and a phase 2b to compare riluzole against a placebo.

Research Summary

The RILUSCI trial is designed to assess the safety and efficacy of riluzole in treating spasticity in patients with chronic spinal cord injury (SCI). The study employs a phase 1b/2b adaptive, multicenter, randomized, double-blind, placebo-controlled design to determine the minimal effective dose of riluzole and its impact on spasticity, pain, and quality of life. The trial is innovative as it focuses on the chronic phase of SCI, aiming to provide a new treatment option for spasticity by repurposing an existing drug, riluzole.

Practical Implications

Potential New Treatment

Riluzole could offer a new therapeutic option for managing spasticity in chronic SCI patients, addressing an unmet clinical need.

Drug Repurposing

Successful repurposing of riluzole could expedite the availability of a new treatment, leveraging its established safety profile.

Improved Quality of Life

Effective reduction of spasticity could improve patients' mobility, reduce pain, and enhance their overall quality of life.

Study Limitations

1
The strict exclusion criteria have complicated and slowed down the rate of inclusion.
2
The study acknowledges that the success rate of riluzole is not fully known, which could impact the sample size determination.
3
The inter-individual dispersion of riluzole pharmacokinetics (PK) was high.

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