Levetiracetam as Adjunct for Partial
(2000)Objective
Levetiracetam - To evaluate the efficacy and safety of levetiracetam (500 mg BID and 1500 mg BID) as adjunctive therapy for refractory partial seizures in adults.
Study Summary
• Levetiracetam significantly reduced seizure frequency and was well-tolerated in adults with refractory partial seizures.
Intervention
Adjunctive oral levetiracetam 1000 mg/day or 3000 mg/day vs. placebo in patients on stable 1–2 AEDs.
Inclusion Criteria
Aged 16–70 years with ≥2 years of refractory partial seizures, ≥12 seizures in 12 weeks before enrollment, and on 1–2 AEDs.
Study Design
Arms: Placebo vs levetiracetam 1000 mg/day vs levetiracetam 3000 mg/day
Patients per Arm: Placebo: 95; LEV 1000 mg: 98; LEV 3000 mg: 101
Outcome
• Median seizure reduction: 32.5% (1000 mg), 37.1% (3000 mg), 6.8% (placebo). • Median % reduction over placebo: 20.9% (1000 mg), 27.7% (3000 mg). • Responder rates (≥50% reduction): 33.0% (1000 mg), 39.8% (3000 mg), 10.8% (placebo) (p<0.001). • Seizure-free: 3 (1000 mg), 8 (3000 mg), 0 (placebo). • Common adverse events (≥10%): somnolence, dizziness, headache, infection, rhinitis, flu syndrome. • Serious adverse events: 7.1% (1000 mg), 2.0% (3000 mg), 10.5% (placebo).