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ImGettingBetter

01/02/24 6:08 PM

#445458 RE: frrol #445444

Can someone supply the list of what the CGI-I measures? From the PR today

"The other co-primary endpoint, the Clinical Global Impression – Improvement scale (CGI-I), which represents a less granular assessment by the site investigators using a seven-point scoring (one=“very much improved” to seven=“very much worse”), was not met."

Using CGI-I seems very arbitrary unless something dramatic improved in 12 short weeks for such a severe CNS disease. To make this a Co-Primary endpoint seems silly to me. But, I am no expert or a caregiver and maybe that is the point, no real dramatic improvement. I need to go and research the CGI-I list that was required for this trial.
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Steady_T

01/03/24 2:32 AM

#445498 RE: frrol #445444

As understand it in a two primary endpoint trial in most cases if one fails then the secondary endpoints are not calculated.
So in the Excellence trial since the CGI fail to meet its endpoint the secondary endpoints are not meaningful.