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Active control trials: endpoints beyond conventional efficacy and tolerability measures.

Emilio Perucca
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Abstract

Clinical trial endpoints often extend beyond conventional efficacy and tolerability measures. While it is generally assumed that seizure control without major adverse drug effects is by far the most important determinant of quality of life, other factors also are important. Pharmacokinetic endpoints could also provide relevant information for optimal drug use. Outcome measures could reveal drug effects on mood, headache, and sleep disorders, as well as overall quality of life and seizure severity.

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AffectAnticonvulsantsCognitionEpilepsyHumansOutcome Assessment, Health CareQuality of LifeJournal ArticleReview

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Emilio Perucca. 2006. Active control trials: endpoints beyond conventional efficacy and tolerability measures.. https://doi.org/10.1016/j.eplepsyres.2005.09.026

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