WASHINGTON (AP) _ The Food and Drug Administration has approved a new drug to help control partial seizures in children with epilepsy.
The drug called Lamictal can be taken with existing epilepsy treatments to reduce the frequency of seizures in children between the ages of two and 16, manufacturer GlaxoSmithKline said Monday.
Other antiepilepsy drugs have been available for adults but they have not been as effective in treating children, researchers said. Of the 2.3 million Americans with epilepsy, about 300,000 are under 14.
``In the overall scope of drug treatment for epilepsy, this is a major step forward,'' said Michael Duchowny, a professor of clinical neurology at the University of Miami medical school, who conducted a clinical study of Lamictal.
``If we can reduce the seizure rates, we have a very real chance at improving the quality of life for children with epilepsy,'' he said.
In the clinical study of 199 patients, 42 percent treated with Lamictal experienced a 50 percent reduction in the frequency of partial seizures, compared to 16 percent of patient who received a placebo. Patients treated with Lamictal also experienced more days without seizures than those in the placebo group.
Duchowny said another benefit of the medication is that few of the children in the trial study suffered side effects.
Of 98 subjects given Lamictal at doses higher than currently recommended for pediatric patients, five left the study because of adverse side effects. Two patients were hospitalized for a serious rash, which improved after the patients stopped taking the drug.
By comparison, six of the 101 subjects given a placebo left the study because of adverse side effects, GlaxoSmithKline said.
Partial seizures, the most common symptom of epilepsy, affect about 70 percent of all people with the illness. The seizures are caused by abnormal electrical activity in the brain and may include a dazed state, lipsmacking or jerking movements of certain body parts.