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Zolmitriptan Nasal Spray Demonstrates Rapid Efficacy for Treatment of Cluster Headache: Presented at IHS

By Claire Sowerbutt

KYOTO, JAPAN -- October 17, 2005 -- New data on the intranasal administration of zolmitriptan demonstrate significant efficacy in the treatment of cluster headache, with a rapid onset of action.

Peter J. Goadsby, MD, PhD, professor of clinical neurology, Institute of Neurology, University College of London, London, United Kingdom, presented the findings here in an oral presentation on October 12^th at the 12^th Congress of the International Headache Society (IHS).

Cluster headache is among the most painful type of headache known, and occurs very rapidly. Therefore, all treatments must have a rapid onset of action. The current mainstay therapies are subcutaneous sumatriptan, and oxygen.

The primary endpoint of the zolmitriptan study was combined rate of response at 30 minutes over 3 migraine attacks. The multicenter, placebo-controlled, double-blind, 2-way crossover study randomized 92 patients to intranasal zolmitriptan 5 mg and 10 mg, or to intranasal placebo. Secondary endpoints included pain-free status at 30 minutes and effects on cranial autonomic symptoms.

Specifically, 42% of patients on zolmitriptan 5 mg reported headache relief within 30 minutes of administration (P < .003 vs placebo), as did 63% of patients in the 10-mg arm (P < .002 vs placebo). With respect to pain-free status at 30 minutes posttreatment, 28% (P < .003 vs placebo) and 50% (P < .002 vs placebo) responded to both the 5-mg and 10-mg dose, respectively.

"It's perfectly clear cut in this placebo-controlled trial that zolmitriptan is effective in acute cluster headache," Dr. Goadsby said during his presentation.

He noted that no serious adverse events were reported in either the placebo or active treatment arms.

"An advantage of the 5-mg dose in this setting is that there is good safety data for taking 15 mg/day of zolmitriptan. If you are not a person who suffers from cluster headache this might not seem important, but if you are a cluster headache patient it means you can take 3 courses of treatment a day -- if you have 3 attacks a day, that's a big difference to your life," Dr. Goadsby said.

"Evidence is the core to take our field forward, and I offer this evidence for clinical practice in future," he concluded.


[Presentation title: Zolmitriptan Nasal Spray is Effective in the Acute Treatment of Cluster Headache: A Double-Blind, Placebo-Controlled Cross-Over Study. Poster C024]

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