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

Michael G. Fehlings, Kee D Kim, Bizhan Aarabi, Marco Rizzo, Lisa M. Bond, Lisa McKerracher, Alexander R. Vaccaro, David O. Okonkwo

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Traumatic spinal cord injury (SCI) is associated with a lifetime of disability stemming from loss of motor, sensory, and autonomic functions; these losses, along with increased comorbid sequelae, negatively impact health outcomes and quality of life. Early decompression surgery post-SCI can enhance patient outcomes, but does not directly facilitate neural repair and regeneration. Currently, there are no U.S. Food and Drug Administration-approved pharmacological therapies to augment motor function and functional recovery in individuals with traumatic SCI. After an SCI, the enzyme, Rho, is activated by growth-inhibitory factors and regulates events that culminate in collapse of the neuronal growth cone, failure of axonal regeneration, and, ultimately, failure of motor and functional recovery. Inhibition of Rho activation is a potential treatment for injuries such as traumatic SCI. VX-210, an investigational agent, inhibits Rho. When administered extradurally after decompression (corpectomy or laminectomy) and stabilization surgery in a phase 1/2a study, VX-210 was well tolerated. Here, we describe the design of the SPRING trial, a multicenter, phase 2b/3, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of VX-210 (NCT02669849). A subset of patients with acute traumatic cervical SCI is currently being enrolled in the United States and Canada. Medical, neurological, and functional changes are evaluated at 6 weeks and at 3, 6, and 12 months after VX-210 administration. Efficacy will be assessed by the primary outcome measure, change in upper extremity motor score at 6 months post-treatment, and by secondary outcomes that include question-based and task-based evaluations of functional recovery.

Original languageEnglish (US)
Pages (from-to)1049-1056
Number of pages8
JournalJournal of Neurotrauma
Volume35
Issue number9
DOIs
StatePublished - May 1 2018

Fingerprint

Spinal Cord Injuries
Clinical Trials
Decompression
Regeneration
Growth Cones
Laminectomy
Recovery of Function
Controlled Clinical Trials
United States Food and Drug Administration
Upper Extremity
Multicenter Studies
Canada
VX
Cervical Cord
Inhibition (Psychology)
Placebos
Quality of Life
Outcome Assessment (Health Care)
Pharmacology
Safety

Keywords

  • motor recovery
  • Rho inhibition
  • spinal cord injury
  • SPRING trial
  • VX-210

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Rho Inhibitor VX-210 in Acute Traumatic Subaxial Cervical Spinal Cord Injury : Design of the SPinal Cord Injury Rho INhibition InvestiGation (SPRING) Clinical Trial. / Fehlings, Michael G.; Kim, Kee D; Aarabi, Bizhan; Rizzo, Marco; Bond, Lisa M.; McKerracher, Lisa; Vaccaro, Alexander R.; Okonkwo, David O.

In: Journal of Neurotrauma, Vol. 35, No. 9, 01.05.2018, p. 1049-1056.

Research output: Contribution to journalArticle

Fehlings, Michael G. ; Kim, Kee D ; Aarabi, Bizhan ; Rizzo, Marco ; Bond, Lisa M. ; McKerracher, Lisa ; Vaccaro, Alexander R. ; Okonkwo, David O. / Rho Inhibitor VX-210 in Acute Traumatic Subaxial Cervical Spinal Cord Injury : Design of the SPinal Cord Injury Rho INhibition InvestiGation (SPRING) Clinical Trial. In: Journal of Neurotrauma. 2018 ; Vol. 35, No. 9. pp. 1049-1056.
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