Clinical Trial Issues

In the early 1980s several pharmaceutical companies became attracted to the idea of discovering neuroprotective drugs for the acute treatment of stroke and CNS injury. As a result, several new compound entities were discovered that were entered into development, with some making their way into large double-blind, multicenter, phase III clinical trials for stroke (ischemic and SAH), TBI, and/or SCI. These efforts, which dominated neuroprotective clinical trials in the 1980s and 1990s, were primarily directed at three general pharmacological mechanistic strategies to interrupt secondary injury processes:

1. inhibition of glutamate-mediated excitotoxicity (i.e., glutamate receptor antagonists; GABA agonists)

2. reduction of intracellular calcium overload (L-type calcium channel blockers)

3. interruption of reactive-oxygen-mediated damage (i.e., free radical scavengers/antioxidants).

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