Rho Inhibitor VX-210 in Acute Traumatic Subaxial Cervical Spinal Cord Injury: Design of the SPinal Cord Injury Rho INhibition InvestiGation (SPRING) Clinical Trial

JOURNAL OF NEUROTRAUMA, 2018 · DOI: 10.1089/neu.2017.5434 · Published: May 1, 2018

Spinal Cord Injury Neurology Research Methodology & Design

Simple Explanation

Traumatic spinal cord injury (SCI) often leads to lasting disabilities because it impairs motor, sensory, and autonomic functions, impacting health and quality of life. While early surgery can help, it doesn't directly repair nerve damage. After a spinal cord injury (SCI), an enzyme called Rho becomes active due to inhibitory factors, hindering nerve regeneration. VX-210 aims to inhibit Rho activation, potentially improving motor and functional recovery. The SPRING trial is designed to test VX-210's ability to improve motor recovery after acute cervical SCI. The trial assesses medical, neurological, and functional changes over 12 months to determine if VX-210 is effective and safe.

Study Duration

12 Months

Participants

Approximately 100 patients with acute traumatic cervical SCI

Evidence Level

Level 2b/3, Randomized, double-blind, placebo-controlled clinical trial

Key Findings

1
VX-210 inhibits Rho, an enzyme activated post-SCI that prevents nerve regeneration.
2
Pre-clinical studies show VX-210 has neuroregenerative and protective effects, promoting functional recovery post-SCI.
3
A Phase 1/2a trial suggested motor strength improvement in cervical SCI patients treated with VX-210 compared to natural history studies.

Research Summary

The SPRING trial is a phase 2b/3 study evaluating VX-210's efficacy and safety in acute traumatic cervical SCI patients. It aims to determine if VX-210 can augment motor recovery. The primary outcome measure is the change in upper extremity motor score (UEMS) at 6 months post-treatment. Secondary outcomes include question-based and task-based evaluations of functional recovery. The study uses a randomized, double-blind, placebo-controlled design, enrolling approximately 100 patients across multiple sites in the US and Canada. Follow-up assessments are conducted at 6 weeks and 3, 6, and 12 months post-treatment.

Practical Implications

Potential New Therapy

VX-210 could become the first FDA-approved pharmacological treatment to improve motor function and functional recovery in SCI patients.

Improved Patient Autonomy

Even partial restoration of motor function may significantly enhance patient autonomy and quality of life, reducing the need for attendant care.

Advancement of SCI Treatment

The SPRING trial's results will contribute to the understanding of Rho inhibition's role in SCI recovery and may inform future treatment strategies.

Study Limitations

1
The study focuses specifically on acute traumatic cervical SCI, limiting generalizability to other types of SCI.
2
Efficacy is primarily assessed by UEMS, which may not capture all aspects of functional recovery.
3
The interim analysis may lead to early termination of the study for futility.

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