Results from a clinical trial (NCT02408523) of lacosamide for the treatment of primary generalized tonic-clonic seizure (PGTCS) were published in the Journal of Neurology, Neurosurgery, and Psychiatry. Data showed treatment with lacosamide (Vimpat; UCB, Atlanta, GA) significantly lowered the risk of having a second PGTCS during the 24-week treatment (hazard ratio [HR] 0.540; P<0.001) period. Participants treated with lacosamide had a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, P=.011).
"This phase 3 trial demonstrated that by adding lacosamide to existing antiseizure medications, IGE patients with uncontrolled PGTCS experienced a higher rate of seizure freedom, suggesting lacosamide could be a valuable adjunctive therapy in this patient population," said David Vossler, MD, FAAN FACNS FAES, Department of Neurology, University of Washington, USA.
The participants with IGE and PGTCS were able to tolerate lacosamide in general. The most common adverse events (≥10%) seen with lacosamide were dizziness (23.1%), somnolence (16.5%), and headache (14.0%). Dizziness and headaches were more common in lacosamide than in placebo.
The phase 3 study enrolled 242 participants (≥4 years of age) with idiopathic generalized epilepsy (IGE) who were randomly assigned 1:1 to receive lacosamide or placebo (twice daily) in addition to their usual epilepsy treatment. Of all types of epilepsies, IGEs make up 20% to 40% and are characterized by different forms of generalized seizures (eg, absence, myoclonic, and PGTCS). Generalized tonic-clonic seizures are associated with an increased risk of injury, and having 3 or more in a year increases the risk of sudden unexpected death in epilepsy (SUDEP) 15-fold.
"UCB remains committed to strengthening our leadership in epilepsy and to investigating new approaches and innovative solutions to deliver improved outcomes and experiences to the global epilepsy community. This applies equally to our current expansive in-market epilepsy portfolio as well as to our exciting pipeline," explained Charl van Zyl, executive vice president & head of Neurology Solutions, UCB.
Lacosamide is not approved treatment for PGTCS currently. Regulatory reviews for adjunctive treatment of PGTCS with lacosamide are underway in the US, Europe, Japan, and Australia.
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Jill M. Giordano Farmer, DO