Phase III data on Vimpat in primary generalized tonic-clonic seizures published in Journal of Neurology, Neurosurgery & Psychiatry.- UCB

UCB has announced the publication of the Phase III study results of Vimpat (lacosamide) as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), in the Journal of Neurology, Neurosurgery & Psychiatry. The Phase III study enrolled 242 patients ( greater than 4 years of age) with idiopathic generalized epilepsy (IGE) who were randomised 1:1 to receive lacosamide or placebo (twice daily) in addition to their current epilepsy treatment. The primary endpoint was time to second primary generalized tonic-clonic seizure (PGTCS) during the 24-week (166-day) treatment period. Treatment with lacosamide resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment (HR 0.540; p<0.001) and a significantly higher rate of freedom from pgtcs during the treatment period compared with placebo (31.3% vs 17.2%, p="0.011)." lacosamide was generally tolerated in patients with ige and pgtcs. the most common treatment-emergent adverse events ( greater than 10%) with lacosamide were dizziness (23.1%), somnolence (16.5%) and headache (14.0%). the incidences of dizziness and headache were numerically higher with lacosamide than placebo. vimpat is currently not approved for pgtcs in any country in the world. regulatory reviews for use of vimpat as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy four years of age and older compared to placebo are currently underway in the u.s., eu, japan, and australia. “this phase iii trial demonstrated that by adding lacosamide to existing anti-seizure medications, ige patients with uncontrolled primary generalized tonic-clonic seizures 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. see-vossler dg , et al. "efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial". j neurol neurosurg psychiatry 2020;0:1–9. doi:10.1136 jnnp-2020-323524.>