Efficacy and tolerability of low versus standard daily doses of antiseizure medications in newly diagnosed focal epilepsy. A multicenter, randomized, single-blind, non-inferiority trial (STANDLOW).

Objective: The STANDLOW trial investigated whether first-line antiseizure monotherapy with low doses has a similar efficacy to standard doses, but with fewer adverse events, improved quality of life, and reduced costs for the National Health System.

Methods: Multicenter, randomized, parallel-arm, single-blind, non-inferiority trial, comparing low dose versus standard dose of antiseizure medications (carbamazepine, levetiracetam, valproate, zonisamide, oxcarbazepine, topiramate, lamotrigine, gabapentin, lacosamide) in adults with newly diagnosed focal epilepsy.

Results: The intention-to-treat (ITT) population consisted of 58 randomized patients, 29 in the low dose arm and 29 in the standard dose arm, 27 (46.