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Anti-Epileptic Agent Levetiracetam Reduces Symptoms Among Transformed Migraine Patients: Presented at AAN

By Ed Susman

SAN FRANCISCO, CA -- April 29, 2004 -- Patients severely disabled by almost daily headaches can obtain considerable relief by adding the anti-epileptic drug levetiracetam to their medication regimen, researchers report.

"We are not curing people with transformed migraines," said Alan Rapoport, MD, Medical Director and founder, New England Center for Headache, Stamford, Connecticut, "but we are helping people."

After 3 months of treating 36 patients with levetiracetam, a drug approved for treatment of epilepsy, the number of days patients had with moderate or severe headaches decreased from an average of 16.8 to 9.7 per month (P <.01).

The Migraine Disability Assessment Score (MIDAS) decreased from about 63 to about 41 (P =.01).

"The treatment of transformed migraine poses a major challenge for the clinician," said co-author, Marcelo Bigal, MD, Assistant Professor of Neurology, Albert Einstein College of Medicine, The Bronx, New York. "Transformed migraine is the most frequent subtype of chronic daily headache seen in the specialty clinic. Most preventive agents used for transformed migraine have not been examined specifically for the treatment of this syndrome."

The open label trial follows previous observations that levetiracetam appeared effective in patients with refractory headaches, the researchers said.

In his poster presentation at the American Academy of Neurology 56^th Annual Meeting, Dr. Rapoport said he recruited subjects who had headache despite taking a preventive drug, but had not tried more than three preventive drugs and had not attempted more than one antiepileptic drug to control the headaches.

Patients already taking preventive drugs were allowed to continue on them if they had been on a stable dose for more than 30 days. Patients were begun on levetiracetam on a dose of 250 mg taken at bedtime and increased by 250 mg every 5^th day up to a dose of 1000 mg at bedtime. After the first month of dose adjustment, the dose could be raised further over the next 2 weeks up to a total dose of 3000 mg per day in two divided doses.

"While this study was just for 3 months, we would predict that improvement would continue if patients continue to take levetiracetam," Dr. Bigal said. He said about 20% of patients reported some form of adverse event, mainly drowsiness, somnolence or a tired feeling.

"That is higher than we see in clinical experience," said Dr. Rapoport, "and may simply be that we are asking the patients in the clinical trials about possible side effects rather than allowing them to name them without prompting." Dr. Bigal also noted that these patients were on other drugs as well and the higher rate of adverse effects might be due to drug-drug interactions.

Madeleine Kitaj, MD, Director, Kitaj Headache Center, Southbury, Connecticut, and Attending Physician, Griffin Hospital, Derby, Connecticut, said it makes sense to use antiepileptic drugs in transformed migraine because the purported cause of both migraine and epilepsy is hyperneuronal activity.

"We use antiepileptic drugs such as levetiracetam and topiramate every day in the treatment of patients with migraine headaches," said Dr. Kitaj, who was not involved with Dr. Rapoport's study.

The study was funded by UCB Pharma.

[Presentation title: Levetiracetam in the Preventive Treatment of Transformed Migraine. A Prospective Study. Poster #P02.103]

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