SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

This study investigates the use of high-dose ibuprofen, a common anti-inflammatory drug, for treating acute spinal cord injuries (SCI). Ibuprofen can block an enzyme called RhoA, which prevents nerve cells from regrowing after injury. The study aims to see if high doses of ibuprofen can help improve motor recovery after SCI. The study will enroll 12 patients with motor-complete SCI and will be treated with ibuprofen for either 4 or 12 weeks. Researchers will closely monitor patients for safety, looking for side effects like gastrointestinal bleeding. They will also assess whether ibuprofen has any effect on neurological recovery, neuropathic pain, and heterotopic ossifications. This trial is designed to see if high-dose ibuprofen is safe and tolerable for SCI patients, and to gather initial data on whether it might help with recovery. The results will be used to plan a larger, more rigorous clinical trial in the future.

• 1
  Preclinical evidence suggests that ibuprofen, through Rho inhibition, may enhance motor recovery after SCI. Meta-analysis supported this, showing a 20.2% improvement in motor outcome with ibuprofen/indometacin treatment compared to controls.
• 2
  Ibuprofen may also limit secondary damage after SCI by reducing inflammation, neuropathic pain, and heterotopic ossifications.
• 3
  The primary safety endpoint of the trial is the occurrence of serious adverse events, specifically gastroduodenal bleedings, while secondary endpoints include pharmacokinetics, feasibility, and preliminary effects on neurological recovery.