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Re: Abel and Cabel post# 173275

Thursday, 11/29/2018 11:21:58 AM

Thursday, November 29, 2018 11:21:58 AM

Post# of 459742
WOW - wasn't really expecting that..

Perhaps the FDA was willing to be more relaxed about 18 or over. If successful off label for kids will be allowed.

"Other Outcome Measures" are telling IMO they support the universal CNS theory.


Other Outcome Measures:
Anxiety, Depression, and Mood Scale (ADAMS) [ Time Frame: 7 weeks ]
Anxiety, Depression, and Mood Scale (ADAMS)

Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: 7 weeks ]
Children's Sleep Habits Questionnaire (CSHQ)

Visual Analog Scale (VAS) [ Time Frame: 7 weeks ]
Visual Analog Scale (VAS)

Seizure Frequency via seizure diary [ Time Frame: 7 weeks ]
Seizure Frequency via seizure diary

Genetic variant SIGMAR1, COMT [ Time Frame: 7 weeks ]
Pre-specified endpoint

Glutamate Plasma Concentration [ Time Frame: 7 weeks ]
Biomarker

GABA Plasma Concentration [ Time Frame: 7 weeks ]
Biomarker





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