Compared with placebo, treatment with lacosamide significantly lowered the risk of a second PGTCS over the 24-week treatment period, researchers report in the Journal of Neurology, Neurosurgery and Psychiatry.
The phase 3, double-blind trial also found that lacosamide (Vimpat, UCB Pharma) was generally safe when used as adjunct therapy in pediatric and adult patients. The drug is approved for the treatment of partial-onset seizures in patients 4 years and older.
Lead author Dr. David Vossler of the University of Washington's Department of Neurology said in a prepared statement sent to Reuters that the trial "demonstrated that by adding lacosamide to existing anti-seizure medications, IGE patients with uncontrolled (PGTCS) experienced a higher rate of seizure freedom than those who received placebo, indicating that lacosamide could be a valuable adjunctive therapy in this patient population."
Between 2015 and 2019, 242 patients age 4 years or older (mean age 27) were randomized to the lacosamide or the placebo group. All had confirmed IGE with classifiable PGTCS before age 30 and at least 24 weeks before entering the study.
Participants received lacosamide or placebo twice daily, with the former being titrated to a target maintenance dose range of 6-8 or 8-12 mg/kg/day or 300-400 mg/day, depending on age and weight. Of the 242 patients, 213 completed the trial.
The risk of developing a second PGTCS during the 24-week treatment period was significantly lower in patients randomized to lacosamide, with Kaplan-Meier survival estimates at the end of the 24-week treatment period of 55.3% versus 33.4% with placebo (P<0.001).
One in 10 patients receiving lacosamide experienced worsening of seizures during treatment compared to between 14.9% and 16.5% of patients on placebo.
Ninety-six (79.3%) patients on lacosamide and 79 (65.3%) on placebo had treatment-emergent adverse events. The most frequently reported events with lacosamide were dizziness, somnolence and headache, with incidences of dizziness and headache numerically higher with lacosamide than placebo.
Eight patients (6.6%) receiving lacosamide experienced a serious adverse event, including abdominal pain, status epilepticus, vomiting, grand mal convulsion and asthenia. Serious adverse events occurred in four patients om placebo (3.3%).
Eleven (9.1%) patients on lacosamide and five (4.1%) on placebo discontinued due to adverse events. The only such events to lead to discontinuation in more than one patient on lacosamide were dizziness and suicidal ideation (two patients each).
Dr. Vossler noted that lacosamide is currently not approved for PGTCS anywhere in the world, although it was approved in the United States in 2008 as adjunct therapy (and later as monotherapy) for focal-onset seizures.
Dr. Dawn Eliashiv, co-director of the Seizure Disorder Center at the University of California, Los Angeles, told Reuters Health by email that lacosamide is a third-generation antiseizure medication that works on the slow sodium channels to prevent seizures. It's well tolerated and is without many interactions with other medications, she added.
This study, Dr. Eliashiv noted, "is important as it is a double-blind placebo-controlled study that gives access to a well-tolerated drug to many patients with generalized epilepsy."
Dr. Eliashiv did not participate in the research.
The study was funded by UCB Pharma. Dr. Vossler has financial ties to the company, as do several of his coauthors.
By Scott Baltic
SOURCE: https://bit.ly/2EcCldX Journal of Neurology, Neurosurgery and Psychiatry, online September 15, 2020.
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