An immediate antiepileptic drug regimen reduced short-term (2-y) recurrence of seizures more than a deferred regimen.

M e t h o d s Design: Randomized controlled trial. Allocation: Concealed.* Blinding: Unblinded.* Follow-up period: 2 and 5 years. Setting: Centers in the United Kingdom, India, Chile, Hungary, Italy, the Netherlands, Poland, Portugal, Slovakia, and Yugoslavia. Patients: 1443 patients ≥ 1 month of age (mean age 25 y, 57% men) with documented history of ≥ 1 clinically definite, spontaneous, unprovoked epileptic seizure (excluding febrile convulsions or acute symptomatic seizures) who, along with their clinicians, were uncertain whether to proceed with AED treatment. Exclusion criteria were current receipt of AEDs other than a shortacting drug to treat serial seizures or status, previous prophylactic treatment for acute symptomatic seizures, or progressive disease. Intervention: Patients were stratified by center and number of seizures at baseline (single or ≥ 2 seizures) and allocated to an immediate AED regimen (type, dose, and duration of AED was chosen according to the clinician’s usual practice) (n = 722) or a deferred AED regimen (no AED drugs until both clinician and patient agreed that treatment was necessary) (n = 721). Outcomes: First seizure of any type, first tonic–clinic seizure, 2-year remission of seizures, and adverse effects. Patient follow-up: 86% (intention-to-treat analysis).