Key result
Lacosamide up to 800 mg/day does not prolong the QTc interval versus placebo.
Why the study?
The potential of lacosamide to prolong the corrected QT interval (QTc) and affect cardiac conduction parameters required evaluation for cardiac safety.
Does lacosamide prolong the corrected QT interval (QTc) in healthy volunteers?
RCT
Double-blind
randomized
Does lacosamide prolong the corrected QT interval (QTc) in healthy volunteers?
Mean Difference: -4.3
Lacosamide at doses up to 800 mg/day does not prolong the QTc interval, supporting its cardiac safety profile regarding repolarization.
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Supports lacosamide use in patients with cardiac comorbidity; confirms QTc safety in randomized data.
Kropeit et al. (2015) conducted an RCT in Healthy volunteers. Lacosamide vs. Placebo and moxifloxacin 400 mg/day was evaluated on Maximum time-matched change from baseline in QT interval individually corrected for heart rate (QTcI) (MD -4.3 ms (400 mg/day) and -6.3 ms (800 mg/day), 95% CI upper limits of 90% CI -0.5 and -2.5 ms). Lacosamide at doses up to 800 mg/day did not prolong the QTc interval, with the upper limits of the 90% CI for the mean maximum difference from placebo remaining below the 10 ms non-inferiority margin.
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