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The New England Center for Headache Release: Study Shows Antiepileptic Drug Keppra Benefits Patients With Chronic Migraine


10/19/2005 5:11:05 PM

SAN FRANCISCO, April 27 /PRNewswire/ -- The antiepileptic drug levetiracetam (Keppra(R)) significantly reduced the frequency and impact of headaches in patients diagnosed with transformed migraine, according to a new study presented today at the 56th annual meeting of the American Academy of Neurology (AAN).(1) The study is one of the first to specifically evaluate a daily medication for the prevention of transformed migraine, one of the most common types of chronic daily headache and one that can have a major, negative impact on a person's ability to function and their quality of life.

"Transformed migraine is very challenging to treat, and there are currently no medications approved by the U.S. Food and Drug Administration for prevention of these headache attacks," said lead investigator Alan M. Rapoport, M.D., founder and co-director, The New England Center for Headache, Stamford, CT, and clinical professor of neurology at Columbia University College of Physicians & Surgeons, New York. "Our findings suggest that levetiracetam is a promising drug for the treatment of transformed migraine," he said. Levetiracetam is currently approved by the F.D.A. for the adjunctive treatment of partial-onset seizures in adults.

Study and Findings

The study showed that three months of treatment with levetiracetam significantly improved various headache measures compared to baseline. It reduced:

-- Headache frequency by 35 percent, from 24.9 days of headache/month to 16.2 days of headache/month (p < 0.001) -- The average number of moderate or severe days of headache by 42 percent, from 16.8 days/month to 9.7 days/month (p < 0.01) -- MIDAS (Migraine Disability Assessment) scores by 35 percent, from 62.8 to 40.8 (p < 0.01); and HIT (Headache Impact Test) scores by six percent, from 63.4 to 59.4 (p < 0.01). MIDAS and HIT are standard measures of how much disability is caused by headaches over a three-month period.

"Our findings are encouraging not only because levetiracetam helped many of our patients, but also because most of them had previously failed on standard migraine preventive therapies," said co-investigator Marcelo Bigal, M.D., Ph.D., director of research, The New England Center for Headache, and associate professor, Department of Neurology, Albert Einstein College of Medicine, Bronx, NY. "The next step is to see if the findings can be replicated in a larger, randomized, placebo-controlled trial."

The prospective, open-label study included 36 transformed migraine patients (26 women and 10 men), averaging 46.5 years old. All the participants had previously failed on one, but not more than three preventive drugs, and had taken no more than one antiepileptic drug. After a baseline period, participants received levetiracetam 250 mg/day, and increased it by 250 mg every fifth day up to a dose of 1000 mg/day. After the first month, doses could be further increased to 3000 mg/day. At baseline and monthly intervals during the three-month study, the investigators assessed headache frequency, the number of days with moderate or severe headaches, and MIDAS and HIT scores.

No serious adverse events were reported. Half of the participants reported side effects, with eight (22.2 percent) dropping out of the study because of them. The most common side effects were somnolence (27.7 percent), asthenia (27.7 percent), and anxiety (13.8 percent).

About Transformed Migraine

Also called chronic migraine, transformed migraine (TM) is the most common type of chronic daily headache seen in headache clinics, and is estimated to affect about four percent of the population in the United States or approximately 10 million people. Patients with TM usually have a history of episodic migraine in their teens or 20's, with headaches changing over months and years to become more frequent and with less severe associated symptoms. Eventually, TM becomes a pattern of daily or near daily headaches that may resemble chronic tension-type headaches; it is diagnosed if patients have headaches at least 15 days per month lasting for at least four hours per attack, with a previous history of migraine. Besides being less severe, TM differs from the more common type of migraine in that it is somewhat more bilateral; involves little sensitivity to light or sound; and is usually not accompanied by nausea. People diagnosed with TM, however, can experience occasional attacks of full-blown migraine. Studies have shown that, owing to its increased frequency compared to episodic migraine, TM is associated with much greater disability and decreased quality of life. Often transformed migraine is thought to be the result of the overuse of pain medications and other acute care medications like the triptans.(2) Somewhat different diagnostic criteria for TM have also been developed and are used primarily in Europe.(3)

About The New England Center for Headache

The New England Center for Headache, founded by Drs. Alan Rapoport and Fred Sheftell in 1979, has gained international recognition in the field of headache treatment and research. The Center's medical staff, which includes Dr. Stewart Tepper as medical director, have together written eight books on the subject of headache and contributed over 350 articles, chapters, posters and abstracts to the medical literature. While the Center cannot offer a cure for most types of headache, it works earnestly toward improving the patient's understanding of their headache condition, quality of life and headache control; and toward having fewer headache days each month. The Center is also actively engaged in public education, research and clinical trials on headache. For additional information, see: http://www.headachenech.com/ or call 203-968-1799.

(1) Rapoport AM, Tepper SJ, Sheftell FD, Bigal ME. Levetiracetam in the preventive treatment of transformed migraine: a prospective study. Poster 103 presented at: 56th annual meeting of the American Academy of Neurology, April 24 - May 1, 2004, San Francisco, CA. (2) Lipton RB, Silberstein SD, Stewart WF. An update on the epidemiology of migraine. Headache. 1994 Jun;34(6):319-28. (3) Levin M. Chronic daily headache and the revised international headache society classification. Curr Pain Headache Rep. 2004 Feb;8(1):59-65.

The New England Center for Headache

CONTACT: Jo-Ann Epstein, The New England Center for Headache,+1-203-661-5501, JE@nech.net; Janene Ferrara, Chandler Chicco Agency,+1-212-229-8411, JFerrara@ccapr.com, for The New England Center for Headache



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