A 28-week open-label study of the adjunct antiepileptic drug, lacosamide, showed that it had a low risk of adverse mood effects and a low risk for overall effect on cognition. Similar to prior studies, this study also found a significant reduction in seizure frequency in refractory partial epilepsy associated with adjunct lacosamide.
A total of 34 subjects, average age of 38.8 ± 2.43 years, completed the study. All subjects had uncontrolled partial epilepsy and were observed for a 4-week baseline period. The lacosamide dosage was titrated from 50mg twice daily at Week 1, for 2 weeks, up to a therapeutic dosage as determined by the investigator, to a maximum of 400mg/day.
Results showed no change in overall cognitive scores during the trial. In the full linear model, the residual was normally distributed (Kolmogorov–Smirnov Z=0.546, P=0.927), also the optimal model from the regression (F=9.43, P=0.005) retained the intercept and seizure frequency at the end of the trial (T=-3.07, P=0.005), indicating that there was no significant change in overall cognitive scores.
Similarly, outcomes for mood/quality-of-life indicated no change during the trial. The Kolmogorov-Smirnov test showed the mood/quality-of-life was normally distributed (Z=0.716, P=0.685). The two-sided one-sample t-test result was in line with no significant change (T=0.191, P=0.85).
However, seizure frequency did decrease significantly, which is in-line with result from prior studies. From a baseline of 2.0 ± 2.55 seizures per week at baseline, seizures per week reduced to 1.02 ± 1.72 post-treatment (T=4.59, P<0.0001). Although no difference was noted in severity, as measured by the Liverpool Seizure Severity Scale.
Adverse events decreased from baseline average of 23.82 ± 1.77 to 20.82 ± 1.90 by the end of the trial (N=34, T=1.88, P=0.06). Most common adverse events were mild headaches (n=10), dizziness (n=7), mild tiredness (n=7), and gastrointestinal symptoms (n=7).
The authors wrote, “Our findings are consistent with previous reports; lacosamide does not appear to have negative side effects on mood/quality of life,” whilst they also acknowledged the studies limits considering the small sample size. They concluded by stating that their results suggest lacosamide is, “effective as an adjunct therapy in refractory partial epilepsy.”
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