A pilot study of compassionate use of Levetiracetam in patients with generalised epilepsy.

Levetiracetam (LEV) has proven effective for partial seizures, suggesting the need to trial it in generalised epilepsy. Ten patients with generalised epilepsy were given compassionate use of LEV as a pilot study, attending 7 visits with seizure count (using diary) and compliance checked (pill count) with option for long term use. Seizure frequency was compared to baseline mean of the last 2 months and mean of follow-up. Patients were commenced on 500 mg I b.d, and titrated to a maximum of 3 g/day. There were 10 patients (7 females), aged 28-48, of whom 6 had primary generalised epilepsy (PGE) and 4 Lennox-Gastaut syndrome (LGS). At 7 month evaluation: 1 was seizure-free, 1 was 70% reduced, 3 were > or = 50% reduced, 2 were 30-35% reduced; 1 had no change; 1 was 10% increased and 1 was excluded because confounding pseudo seizures. Follow-up was 8-17 months (mean 13.8). The seizure-free patient became pregnant and had 2 seizures, but has been seizure-free for 2 months, at time of submission. A 16 months are three months seizure-free. One was 50% reduced at months 6 and 7, was 2 months seizure-free but then reverted to 50% per baseline. With respect to LGS, 1 withdrew due to aggression, 2 had 40% and 35% reduction at 13 and 15 months respectively and 1 had 25% increase (10% at 7 months). All patients were compliant. These data suggest that LEV may be effective for generalised epilepsy with a need for a larger clinical trial.