SOURCE: Children's Hospital of Pittsburgh

April 14, 2005 15:00 ET

Children's Hospital of Pittsburgh Study Shows Antiepileptic Drug Levetiracetam Reduces Frequency of Migraines in Children

Treatment Reduced Frequency of Migraines in Children by More Than Two-Thirds

MIAMI BEACH, FL -- (MARKET WIRE) -- April 14, 2005 -- The antiepileptic drug levetiracetam reduced the frequency of migraine headaches in children, according to results of a new Children's Hospital of Pittsburgh study presented today at the 57th annual meeting of the American Academy of Neurology (AAN).(1)

Study results show that treatment with the medication reduced the frequency of headaches by more than two-thirds on average. Approximately three-fourths of the patients who completed at least half of the study had at least a 50 percent decrease in headache frequency and a 50 percent improvement in quality of life.

"Headaches are common and disabling in children and adolescents, and have been reported to account for 25 percent of all new patient diagnoses in a pediatric neurology clinic,(2)" said lead investigator Inna I. Vaisleib, MD, a neurologist at Children's Hospital of Pittsburgh who specializes in migraines and epilepsy in children. "Our findings suggest that levetiracetam can be an effective and well-tolerated agent for the prophylactic treatment of migraine headaches in children, and may be useful for clinicians to consider in selecting a treatment medication."

Many anti-convulsants have been used successfully for the prophylactic treatment of migraine headaches. Levetiracetam is currently approved by the U.S. Food and Drug Administration for the adjunctive treatment of partial-onset seizures in adults.

Study and Findings

The study was a prospective, open-label trial in 30 children and adolescents, age six to 19, who had two or more migraine headaches each week. Over a period of 10 weeks, the participants were given levetiracetam, with dosages adjusted during the first six weeks until it appeared to be effective, after which participants were evaluated for an additional four weeks. The primary measure of improvement was changes in headache frequency. Secondary measures included scores on the PedMIDAS (Pediatric Migraine Disability Assessment), a questionnaire that measures quality of life;(3) headache duration and severity; and the percent of patients who showed responses to the treatment.

Treatment with levetiracetam significantly decreased the average frequency of headaches, from 14.5 per month at the start of the study to 4.5 during the six-week dose-adjustment period and three during the four-week evaluation period (p < 0.05 for both comparisons). Out of 25 patients who had at least 4 weeks of levetiracetam therapy, 20 (80 percent) had at least a 50 percent decrease and nine (36 percent) had at least a 75 percent decrease in headache frequency, and three (12 percent) became headache-free. Headaches worsened in four (16 percent) patients and did not change in one (4 percent).

Levetiracetam also significantly improved PedMIDAS scores, from 27 at baseline to 10 during the six-week dose-adjustment period and nine during the four-week evaluation period (decreased scores indicate improved quality of life) (p < 0.05 for both comparisons). Of 21 patients who completed the six-week dose adjustment period, PedMIDAS scores improved at least 50 percent in 16 patients (76 percent) and 75 percent in 12 (57 percent), became worse in four (19 percent), and did not change in one (5 percent).

There was a trend for a decreased duration of headaches with levetiracetam. No significant change in headache severity was found. Eleven patients in the study dropped out due to non-compliance (four), lack of efficacy (three), feeling better (one) or adverse reactions (delusions and violent behavior, related to levetiracetam, in one, and development of a seizure disorder, not related to levetiracetam, in the other).

"The response to levetiracetam in our study was impressive, although these data are preliminary and full statistical analyses are in process," said Dr. Vaisleib, also an assistant professor of Pediatrics and Neurology, University of Pittsburgh, Pennsylvania. She also said that the findings should be confirmed by additional, larger studies.

The study was funded by a grant from UCB Pharma.

About Migraines

More than 28 million Americans suffer from migraines, which affect three times more women than men. Migraines are most commonly experienced between the ages of 15 and 55, and 70 to 80 percent of sufferers have a family history of migraine. Characteristics of migraines can include: moderate to intense pain on one side of the head, with a pulsating or throbbing quality, affecting daily activities; nausea or vomiting; sensitivity to light and sound; visual disturbances or aura. Attacks last four to 72 hours, sometimes longer.(4) The precise causes of migraines are not fully understood.

Migraines in children are usually expressed differently than in adults, but are nonetheless debilitating. Up to 10.6 percent of children ages 5-15 and 28 percent of adolescents ages 15-19 may have migraine headaches,(3) though the condition is often not diagnosed.

References

1. Vaisleib II, Neft RA, Schor NF. Role of levetiracetam in prohylaxis of migraine headaches in childhood. Abstract P06.009, poster presentation at: 57th Annual Meeting of the American Academy of Neurology (AAN), Miami Beach, Florida. April 9-16, 2005.

2. Rothner, DA. Migraine headaches in children and adolescents. In Maria,BL (ed.) Current management in child neurology, 1999; chapter 8:43-48.

3. Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche MA, Maynard MK. PedMIDAS: development of a questionnaire to assess disability of migraines in children. Neurology 2001 Dec 11;57:2034-2039.

4. National Headache Foundation. Educational Resources: Migraine. Available at: http://www.headaches.org/consumer/topicsheets/migraine.html. Accessed April 3, 2005.

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