A sequential analysis of the first 483 patients enrolled into a Phase II/III trial of Synthelabo's eliprodil in acute ischemic stroke has failed to demonstrate a significant benefit for the drug versus placebo.
Eliprodil is one of a series of glutamate antagonist compounds which are being tested to see if they can limit the progressive damage to neurons which follows an episode of ischemic stroke. These drugs have had a chequered past, initially because of safety concerns and latterly because of some high-profile failures to show efficacy. Towards the end of last year, a similar compound from Ciba, selfotel, was unable to demonstrate increased efficacy versus placebo in a Phase III trial in stroke and traumatic brain injury patients (Marketletter December 11, 1995).
Stroke is a notoriously difficult clinical target, with other products such as Stering's Dismutec (pegorgotein) and Pharmacia & Upjohn's Freedox (tirilazad mesylate) amongst those falling at the efficacy trial hurdle.
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