Levetiracetam Vs Sodium Valproate as First-Line Monotherapy in Childhood Epilepsy: An Open-Label Randomised Controlled Trial from Western India

Abstract

Background: Epilepsy affects nearly 10 million Indian children and is often treated empirically. Evidence comparing broad-spectrum agents in paediatric‐onset epilepsy is limited. We compared the efficacy and tolerability of levetiracetam (LEV) versus sodium valproate (VPA) as initial monotherapy.

Methods: In this open-label parallel RCT (October 2022–March 2024, Udaipur, India) 52 drug-naïve children (1–18 y) with newly diagnosed epilepsy were randomised 1:1 to LEV (20 mg kg⁻¹ day⁻¹) or VPA (20 mg kg⁻¹ day⁻¹). Primary outcome was seizure-free interval over 6 months. Secondary outcomes were seizure recurrence latency, episode duration, need for rescue/adjunctive AEDs, and adverse events (AEs).

Results: Baseline characteristics were comparable (mean age 9.0 ± 4.9 y vs 9.3 ± 5.0 y; males 50 % vs 54 %; generalised-onset 62 % each). Six-month seizure freedom occurred in 77 % (LEV) vs 85 % (VPA) (p = 0.47). Mean time to first recurrence was shorter with LEV (39.7 ± 5.4 days) than VPA (59.4 ± 5.7 days; p < 0.001), yet mean repeat-episode duration favoured LEV (1.7 ± 0.6 min vs 4.0 ± 1.2 min; p < 0.001). No child on LEV required add-on therapy; one VPA recipient did (4 %). AEs were mild: behavioural symptoms predominated with LEV (15 % personality change, 12 % aggression) whereas metabolic/GI effects predominated with VPA (8 % weight-gain, 12 % abdominal pain). No serious or irreversible toxicity occurred.

Conclusion: Both agents provided high seizure-freedom rates. LEV shortened individual seizure duration and eliminated rescue AED need but showed earlier recurrences and more behavioural AEs. VPA achieved longer recurrence-free spans at the cost of metabolic/GI issues. Tailoring first-line therapy to individual comorbidity risk is essential.