New Epilepsy Drug May Significantly Reduce Seizures
Results of a clinical trial show that a new epilepsy drug called perampanel may significantly reduce seizures in individuals who have epilepsy that is difficult to treat. Perampanel has not yet been approved by the Food and Drug Administration (FDA).
A new epilepsy drug is needed for difficult cases
About 3 million people in the United States have some form of epilepsy, according to the Epilepsy Foundation, and an estimated 200,000 new cases of seizures disorders and epilepsy are diagnosed each year. Incidence is greatest in children younger than age 2 and in people older than 65. In 70 percent of new cases, no cause is apparent.
The main treatment options for people with epilepsy are medications, surgery, and vagus nerve stimulation. According to Jacqueline French, MD, with New York University and one of the new study’s authors, “for about one-third of people with epilepsy, the drugs either don’t stop their seizures or the side effects are not tolerable.”
Therefore, this hard-to-treat population of patients would have access to another medication option if perampanel is approved by the FDA. The results of the latest study, which will be presented at the 63rd Annual Meeting of the American Academy of Neurology, April 9-16 in Honolulu, are promising.
The study included 387 individuals who had uncontrolled epilepsy and who were taking one to three anti-seizure medications. Patients were assigned to take either 8 or 12 milligrams (mg) of perampanel or a placebo once daily for 19 weeks along with their regular treatment program.
In a 28-day period, patients who took 12 mg of perampanel showed a 14 percent reduction in seizures compared with patients who took placebo. Researchers observed a nearly 6 percent reduction in seizures in patients who took the 8 mg dose when compared with placebo.
Perampanel is not without side effects. Patients in the study reported ataxia (lack of muscle coordination), dizziness, drowsiness, falls, headache, and irritability.
Seizures can be classified into two main categories: generalized and partial. There are six types of generalized seizures, of which the grand-mal seizure is the most common. Other types include absence, myoclonic, clonic, tonic, and atonic.
Grand-mal, myoclonic, and clonic seizures involve jerking activity, while absence seizures cause a short loss of consciousness with few or no symptoms. Tonic seizures are characterized by stiffening muscles while atonic seizures consist of a loss of muscle tone.
Partial seizures can be simple, complex, or develop into secondary generalized seizures. During simple seizures individuals retain awareness while awareness is lost during complex seizures.
Some of the anti-seizure drugs currently used to treat epilepsy include carbamazepine (Tegretol, Carbatrol), ethosoximide (Zarontin), gabapentin (Neurontin), phenytoin (Dilantin), and topiramate (Topamax), among others.
French explained that their findings “provide further evidence of the effectiveness and safety of perampanel as an added treatment option to reduce seizures.” Investigators plan to submit the new epilepsy drug to the FDA for approval in 2011.
American Academy of Neurology