Phase 2 Clinical Trial of AC105 (Mg/PEG) for Treatment of Acute Spinal Cord Injury (SCI)
Technical Report,30 Sep 2013,29 Sep 2014
Acorda Therapeutics, Inc. Hawthorne United States
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Research has shown that tissue magnesium Mg is rapidly depleted in injured central nervous system CNS, and this depletion correlates with the severity of injury in animal models Heath and Vink, 1999. Exogenously delivered Mg reduces injury in animals Kwon et al., 2009 but conventional systemic Mg therapy is limited by the inability to achieve sufficient CNS levels to be effectively neuroprotective. AC105 is a polyethylene glycol PEG formulation of Mg that was shown to more effectively deliver Mg to the injured CNS. The primary hypothesis of this study was that treatment of people with acute spinal cord injury SCI with the polymer formulation of magnesium known as AC-105 would result in greater normalization of CNS Mg than treatment with saline solutions and potentially improve neurological outcome from injury. This was a Phase 2 double-blind, placebo-controlled study to determine the safety, tolerability and potential activity of AC105 following a regimen of 6 doses over 30 hours in patients with acute SCI. Forty 40 subjects were planned for enrollment into one of the two treatment groups, AC105 or placebo, randomized in a 11 allocation. The study was terminated by the Sponsor due to an insufficient rate of enrollment and patient retention at the time of study termination, a total of 15 subjects had been enrolled.
- Medicine and Medical Research