It looks to be a longer term study of the Lilac patients on the longer term effects on their health (heart, vitals, weight and other parameters).
Acadia have seemed pretty upbeat on the Trofinetide on their last conference calls are they now planning longer term monitoring studies already?
Primary Outcome Measures :
- Percentage of subjects with treatment-emergent adverse events (TAEs), percentage of subjects with serious adverse events (SAEs), and percentage of subjects withdrawals due to adverse events (AEs) [ Time Frame: 32 months ]
- Number and percentage of subjects with post-Baseline potentially clinically important changes in ECG [ Time Frame: 32 months ]
- Number and percentage of subjects with post-Baseline potentially clinically important changes in vital signs [ Time Frame: 32 months ]
- Number and percentage of subjects with post-Baseline potentially clinically important changes in body weight [ Time Frame: 32 months ]
- Number and percentage of subjects with post-Baseline potentially clinically important changes in laboratory parameters [ Time Frame: 32 months ]
Do your own research.
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