PAST AND CURRENT CLINICAL-STUDIES WITH GM-1 GANGLIOSIDE IN ACUTE SPINAL-CORD INJURY

Two recent prospective, randomized, placebo-controlled, double-blinded clinical drug studies in acute spinal cord injury have reported enhan cement of neurologic recovery of motor function. The drugs investigate d in these studies were methylprednisolone and GM-1 ganglioside. Befor e these studies, the treatment of patients with spinal cord injuries h ad been restricted to prevention of further injury to the spinal cord, limiting secondary damage following the initial injury, increasing th e patient's ability to function through intensive rehabilitation, and facilitating any spontaneous recovery of neurologic function. Methylpr ednisolone is a steroid administered at very high levels, and GM-1 is a complex acidic glycolipid found at high levels in cell membranes in the mammalian central nervous system with known neuroprotective and ne urofunctional restoration potential. This article summarizes the previ ously reported Maryland GM-1 clinical trial and presents the clinical and statistical design of a larger clinical trial being conducted with the purpose of verifying a beneficial GM-1 drug effect when administe red with methylprednisolone in acute spinal cord injury.