By Maria Bishop
BOSTON, MA -- May 7, 2007 -- Zolmitriptan nasal spray is effective therapy for the difficult-to-treat and severe condition known as cluster headache, researchers stated here at the American Academy of Neurology (AAN) 59th Annual Meeting.
Cluster headache -- often described as a piercing pain in 1 eye or temple -- is a rare but debilitating condition. They often occur with regular timing, and in 2 or more cluster periods.
Options for acute treatment of cluster headaches are limited, because the attacks build up quickly (within 5 to 15 minutes), noted lead investigator Alan M. Rapoport, MD, assistant clinical professor of neurology, Yale University School of Medicine, New Haven, Connecticut, director, New England Center for Headache, Stamford, Connecticut, and medical director, the Headache Inpatient Unit, Greenwich Hospital, Greenwich, Connecticut.
Dr. Rapoport and colleagues evaluated the efficacy of zolmitriptan, which has fast onset of efficacy in migraine, in patients with cluster headache. Fifty-two adult patients were randomized to a nasal spray of placebo or zolmitriptan (5 mg or 10 mg) administered at the first sign of cluster-headache attack.
Up to 3 attacks were treated per patient, for a total of 151 attacks. For the primary endpoint, the 3 attacks were combined and headache response assessed at 30 minutes, with logistic regression analysis conducted to achieve a common result.
Both treatment doses reached significance at 30 minutes (placebo = 30%, zolmitriptan 5 mg = 50%, zolmitriptan 10 mg = 63.3%). For headache relief, zolmitriptan 10 mg separated from placebo at 10 minutes (24.5% vs 10%). The 5-mg dose separated from placebo at 20 minutes (38.5% vs 20%). For pain-free status, zolmitriptan 10 mg was superior to placebo at 15 minutes (22% vs 6%). Both doses had higher pain-free rates than placebo at 30 minutes (placebo = 20%, zolmitriptan 5 mg = 38.5%, zolmitriptan 10 mg = 46.9%).
Headache intensity was rated by patients using a 5-point scale: none, mild, moderate, severe, or very severe.
Adverse events were mild and typical of the triptan sensations. Adverse events were seen in 16% of those receiving placebo, in 25% of those treated with zolmitriptan 5 mg, and in 33% of those treated with zolmitriptan 10 mg (P <.05). No serious adverse events were reported.
Cluster headache is a trigeminal autonomic cephalgia. Unlike migraine, cluster headaches are diagnosed more often in men.
This study was supported by AstraZeneca.
[Presentation title: Zolmitriptan Nasal Spray in the Acute Treatment of Cluster Headache - A Double-Blind, Placebo-Controlled, Multicentric Study. Abstract P06.026]
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