Epilepsy Clinical Trial
Official title:
Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
The purpose of this study is to determine the effect of lacosamide on mood and quality of life in people with epilepsy.
Lacosamide (LCM) was found in phase 3 studies to have good efficacy and tolerability as
adjunctive treatment in adult patients with uncontrolled partial onset seizures, with or
without secondary generalization. Dose-related adverse drug reactions (ADRs) included
dizziness, headache and nausea, but the incidence of reported mood symptoms was similar to
placebo. The very low incidence of such events, combined with LCM's unique mechanism of
action, suggest that LCM has the potential to be among the few anti-epileptic drugs (AEDs)
without clinically significant mood ADRs.
The effects of LCM on mood states (i.e., worsening or improvement) have not been examined
with standardized measures. In addition, its effects on quality of life (QOL) have not been
explored, although QOL is known to be affected by other AEDs.
The investigators propose to examine the effects of LCM on mood and QOL in a real-world
population of adult patients with partial-onset seizures. To the knowledge of the
investigators, the proposed study will be the first to examine these domains in a
scientifically rigorous fashion in patients treated with LCM. Thus, study results will fill
a current knowledge gap, and will provide important information to clinicians and patients
when considering LCM treatment.
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Observational Model: Case Control, Time Perspective: Prospective
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