Effect of brivaracetam on cardiac repolarisation – a thorough QT study

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Why the study?

Does brivaracetam affect cardiac repolarisation in subjects?

Structured PICO

Does brivaracetam affect cardiac repolarisation in subjects?

Population

184 subjects (n=53 placebo, n=39 brivaracetam 75 mg, n=40 brivaracetam 400 mg, n=52 moxifloxacin)

Intervention

Brivaracetam 75 mg or 400 mg multiple bid doses

Comparator

Double-blind placebo or open-label single-dose moxifloxacin 400 mg (positive control)

Outcome

Largest time-matched mean difference of QTc(SS) change from baseline between drug and placebo (maximum DeltaDeltaQTc(SS))surrogate

Brivaracetam does not prolong the QT interval, suggesting that intensive cardiac monitoring is not required during its clinical use.

No takes yet. Share an insight, caveat, or question.

Brivaracetam shows no QTc prolongation; leaves open whether cardiac monitoring can be safely omitted pending confirmatory data.

Rosillon et al. (2008) studied this question.

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