A new drug called perampanel appears to significantly reduce seizures in people with hard-to-control epilepsy, according to results of the first clinical trial to test the higher 12 mg dose of the drug. The late-breaking research will be presented at the 63rd Annual Meeting of the American Academy of Neurology, April 9-16, 2011, in Honolulu.
"For about one-third of people with epilepsy, the drugs either don't stop their seizures or the side effects are not tolerable," said study author Jacqueline French, MD, with New York University in New York. French is also a Fellow of the American Academy of Neurology. "If this drug is approved by the Food and Drug Administration (FDA), it will be another tool in our arsenal for combating or reducing seizures in people with difficult to treat epilepsy."
The study involved 387 people in the United States and Latin America who had uncontrolled epilepsy and were currently taking one to three other anti-seizure drugs. Participants were assigned to receive either eight or 12 milligrams of perampanel or a placebo pill once daily for 19 weeks in addition to their regular treatment.
Patients who took the 12 milligram dose of perampanel had a 14-percent reduction in seizures in a 28-day period compared to those who took the placebo. Those who took the eight milligram dose cut their seizure frequency by nearly six percent compared to those who took the placebo.
The most common side effects of the drug were dizziness, drowsiness, irritability, headache, falls and ataxia, which is a lack of muscle coordination.
"These findings provide further evidence of the effectiveness and safety of perampanel as an added treatment option to reduce seizures," said French. "Plans are to submit the drug for FDA approval this year."
The study was supported by Eisai Inc.
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