Key result
Eslicarbazepine acetate does not induce clinically significant QTc prolongation versus placebo.
Why the study?
The effect of eslicarbazepine acetate on cardiac repolarization and QTc interval prolongation in healthy adults was investigated to assess cardiac safety.
Does eslicarbazepine acetate prolong the QTcI interval in healthy adult volunteers?
RCT (n=67)
Randomized
Does eslicarbazepine acetate prolong the QTcI interval in healthy adult volunteers?
Effect estimate: upper bound of 95% CI <10 ms
Eslicarbazepine acetate at doses up to 2400 mg daily does not cause clinically significant QTc prolongation in healthy adults.
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Supports QTc safety for eslicarbazepine up to 2400 mg; reinforces cardiac safety evidence for clinical use and trials.
Vaz‐da‐Silva et al. (2011) conducted an RCT in Healthy adult volunteers (n=67). Eslicarbazepine acetate vs. Placebo and moxifloxacin was evaluated on Placebo-corrected change from baseline of the individually corrected QT interval (QTcI) (upper bound of 95% CI <10 ms). Eslicarbazepine acetate 1200 mg and 2400 mg did not induce clinically significant QTcI prolongation, as the upper bound of the 95% CI for placebo-corrected change was <10 ms at all time points.
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