Keppra as adjunctive treatment in idiopathic generalised epilepsy patients with primary generalised tonic-clonic seizures


According to new data, presented at the 59th Annual Meeting of the American Epilepsy Society, approximately one in four patients with poorly controlled idiopathic generalised epilepsy ( IGE ) having primary generalised tonic-clonic ( PGTC ) seizures became free from all types of seizures when Keppra ( Levetiracetam ) was administered as an add-on treatment during a 20 week evaluation period.
In comparison, only one in twelve of those who took a placebo in addition to their usual therapy became seizure free.

Study investigator, Robert Leroy, from the Neurological Clinic of Texas, commented, " These are major seizures which disrupt the working, school and social lives of those who have them. The results show that Keppra significantly reduced PGTC seizures. The tolerability profile is comparable to that seen in studies of Keppra in patients with epilepsy and other types of seizures."

All of the 164 patients aged 4 to 65 years enrolled in the trial had at least three PGTC seizures during the eight weeks prior to treatment, despite taking one or two anti-epileptic drugs ( AEDs ).
After a four-week prospective baseline period, the patients were randomised to either Keppra, up-titrated to 3000 mg/day in adults or a target dose of 60 mg/kg/day in children, or placebo, followed by a 20 week stable dose period.

Treatment with Keppra reduced the weekly PGTC seizure frequency significantly more than placebo ( p=0.004 ).
In the Keppra group, 72.2 % of patients had at least a 50% reduction from combined baseline in PGTC seizure frequency per week during the treatment period, compared with 45.2 % in the placebo group ( p=0.0005 ).
During the 20-week evaluation period 24.1 % of patients treated with Keppra became free from all types of seizures compared with only 8.3% of placebo-treated patients ( p=0.009 ).

A preliminary assessment of safety data showed similar findings to the established safety profile of Keppra.

Source: UCB, 2005


XagenaMedicine2005