Cluster Headaches Effectively Treated With New Nasal Spray

The double-blind trial involved 52 people with cluster headache who used five or 10 milligrams of zolmitriptan nasal spray or placebo to treat 151 separate cluster headache attacks. The study found 63 percent of people treated with the drug at the higher dose reported headache relief at 30 minutes, compared to 50 percent of people taking the lower dose of zolmitriptan nasal spray and 30 percent in the placebo group.

"This is a significant finding and the main endpoint of our study," said study author Alan M. Rapoport, MD, with The New England Center for Headache in Stamford, CT, and Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA in Los Angeles. Rapoport is a Fellow of the American Academy of Neurology. "The 10 milligram dose worked as quickly as 10 minutes in some patients."

"Cluster headache is an extremely severe headache disorder with enormous unmet treatment needs," said Rapoport. "Few medications for cluster headache have been systematically tested, and only one, which involves an injection of sumatriptan, has been FDA approved."

Cluster headache is relatively rare, occurring in less than one-tenth of one percent of the U.S. population. Men are three to four times more likely to suffer from cluster headaches than women. The pain is considered to be the most severe of the primary headache disorders and often peaks within five minutes and remains severe for about one and up to three hours. The pain is usually associated with neurological findings such as a droopy eyelid, small pupil, red and tearing eye, and stuffed and running nostril. All of the symptoms usually occur on the same side as the headache pain.

"Because a cluster headache attack builds up to a crescendo within five to 15 minutes, treatment must be rapid and offer significant relief," said Rapoport. "While the FDA has not approved zolmitriptan nasal spray for use in cluster headaches, it may someday be considered a first-line therapy." Side effects were mild and no serious adverse events were reported during the study.

The study was published in the August 28, 2007, issue of Neurology®, the medical journal of the American Academy of Neurology.