Source: J Clin Otorhinolaryngol  |  Posted 7 years ago

By Bonnie Darves

NEW ORLEANS, LA -- December 7, 2004 -- Physicians who treat children with poorly controlled partial-onset seizures may soon have another therapeutic option in levetiracetam (Keppra), according to a new study presented here at the American Epilespy Society Annual Meeting.

In a large, multicenter, double-blind trial that included more than 200 patients, the Keppra, currently only approved as adjunctive therapy for patients age 16 and older, was found to reduce seizure frequency by at least 50% without producing serious adverse events in about half of patients studied, said the trial chief investigator Tracy Glauser, MD, director, Comprehensive Epilepsy Program, Cincinnati Children's Hospital in Ohio.

"In some patients, we actually saw a seizure reduction of 75%, and a few were actually seizure free" during some period of the trial's 8-week evaluation period, Dr. Glauser said. "These new data show that Keppra may become a valuable treatment option for this difficult-to-treat population."

The drug, now widely prescribed for adults, is being studied in children who have responded poorly to multiple antiepileptic agents and who have high frequency of seizures.

Of the 216 patients studied, data was available for 198. Of these, 101 took levetiracetam in doses up to 60 mg/kg per day and the remainder were given placebo. Participants ranged in age from 4 to 16 years. To meet inclusion criteria, participants had to experience at least one partial-onset seizure per week. The majority of children had far higher frequency, Dr. Glauser noted, adding that the mean weekly seizure frequency was 19. All patients in the study had been poorly controlled with multiple agents, and some participants had been treated with as many as nine other medications before starting the trial.

The most common adverse event was somnolence, which affected 22.8% of patients taking levetiracetam and 11.3% of those on placebo. A tendency toward hostility and accidental injuries were also more prevalent in the children taking the drug, Dr. Glauser said. In general, the drug's adverse effect profile was similar to that witnessed in adults who take the medication, he added.

[Presentation title: "Multicenter, Double-Blind, Placebo-Controlled Trial Of Adjunctive Levetiracetam (Keppra?) Therapy (Up To 60 Mg/Kg/Day) In Pediatric Patients With Refractory Partial Epilepsy." Abstract B.03]