Thursday, March 19, 2009 7:55:30 PM
The wild card is magnitude of change. It is possible they could see a pattern, or lack thereof, long before the study is officially completed. And they could decide to unblind early.
As Ememem notes, the other wild card will be side effect profile. If half the patients maintain their same sleep cycle on the third night, and the other half are lying there with their eyes wide open due to insomnia, that would be the side effect issue. I am not predicting that, I think that if CX1739 had a marked awakening effect (and my understanding is that the Ampakines vary in that), this might have shown up in the safety testing, some increase in insomnia. If that had occurred, Cortex might well have decided to not roll these dice. That doesn't guarantee an absence of an insomnia side effect, since I suspect the Phase I patients were not dosed at hour of sleep. But they would have been looking for anything that looked stimulating/alerting.
NeuroInvestment
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