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New Treatment Explored for Cluster Headaches
Date:8/30/2007

Migraine nasal spray showed promising results in small study

THURSDAY, Aug. 30 (HealthDay News) -- The severely painful type of headache called cluster headaches respond to a medication frequently used for migraines, a new study found.

The research shows that zolmitriptan nasal spray -- part of a family of migraine drugs called triptans -- can reduce pain within 10 minutes to 30 minutes, depending upon the dosage, according to Dr. Alan M. Rapoport, the study's lead author.

"People with cluster headaches have such severe headaches they can't stand it. It's the worse type of headache that we know of. It comes on very quickly, so you need to have a medication that works quickly and is easy to use," said Rapoport, who conducted the research when he was director of The New England Center for Headache in Stamford, Conn.

With a spray of zolmitriptan in one nostril (5 milligrams) or two nostrils (10 milligrams), "We've shown [it] will rapidly relieve cluster headaches in a significant number of people," Rapoport said.

The study found that 50 percent of the patients using the lower dose and 63 percent using the higher dose experienced pain reduction within 30 minutes. That compared to only 30 percent of the study participants receiving placebos. At 30 minutes, 46.9 percent of the patients using the high dose and 38.5 percent using the low dose were pain-free.

The new findings were published in the Aug. 28 issue of the journal Neurology. They confirm similar findings in a European study published last year in the Archives of Neurology. Both studies were funded by AstraZeneca, the maker of the zolmitriptan nasal spray.

Cluster headaches are "one-sided" with pain that can "peak" in five minutes and remain severe for 30 minutes to 180 minutes. While they affect less than 1 percent of the U.S. population, they occur much more frequently in men than women, the study authors said.

The most common form of cluster headaches is marked by sudden attacks over periods of one to two months, during which time a person may experience between one and three attacks a day, said Rapoport, now a clinical professor of neurology at the University of California, Los Angeles, David Geffen School of Medicine. About 14 percent of people with cluster headaches have an inherited form that runs in families, he added.

Dr. Charles Flippen, of the UCLA Headache Research and Treatment Program, said the new research "gives us another bow in the quiver, so to speak. It's been established that triptans are effective medication for cluster headaches. Right now, the gold standard is subcutaneous sumatriptan. Because of the delivery method for that medication, there is a relative limit on how many doses you have within a day or week's period of time," he said.

"The [zolmitriptan] nasal spray will allow a little more dosing within that period of time," Flippen said, although the U.S. Food and Drug Administration has not yet approved this usage or a standard for dosages. The spray is "another method of helping a small but significantly comprised group of patients that suffer from a disorder than has a limited number of therapeutic options," he added.

Rapoport said the 52 study participants, aged 23 to 65, used the zolmitriptan nasal spray at most to manage only three attacks of individual episodes. The study didn't show what side effects might occur with more frequent usage, he added. Before the FDA will consider approval of the drug for cluster headaches, a longer-term study is likely needed, he said.

Dr. Seymour Diamond, executive chairman of the National Headache Foundation, said he is concerned about the use of triptans such as zolmitriptan. He said he'd be "very cautious" about using triptans in anyone over age 55 because of the potential cardiovascular effects.

"I wouldn't mind if a patient took it for one attack, but I would be very hesitant to use it in my practice prophylatically, on a daily basis," Diamond said.

More information

Learn more about cluster headaches from the American Academy of Family Physicians.



SOURCES: Alan M. Rapoport, M.D., clinical professor of neurology, David Geffen School of Medicine, University of California, Los Angeles; Charles Flippen, M.D., associate professor of neurology, David Geffen School of Medicine, University of California, Los Angeles; Seymour Diamond, M.D., executive chairman, National Headache Foundation, Chicago; Aug. 28, 2007, Neurology


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