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A Randomized, Placebo-Controlled, Double-blind Crossover Study

Elizabeth Cittadini, MD; Arne May, MD; Andreas Straube, MD; Stefan Evers, MD; Gennaro Bussone, MD; Peter J. Goadsby, MD, PhD

Arch Neurol. 2006;63:1537-1542. Published online September 11, 2006 (doi:10.1001/archneur.63.11.nct60002).

Background  Cluster headache is a form of primary headache in which attacks are rapid in onset with very severe pain. The mainstays of acute therapy are inhaled oxygen and sumatriptan succinate injection.

Objective  To evaluate zolmitriptan nasal spray in the acute treatment of cluster headache.

Methods  Ninety-two patients, aged 40 ± 10 years (mean ± SD) (80 men and 12 women), with International Headache Society–defined cluster headache were randomized into a placebo-controlled, double-blind crossover study. Patients treated 3 headache attacks using placebo for 1 attack, 5 mg of zolmitriptan nasal spray (ZNS5) for 1 attack, and 10 mg of zolmitriptan nasal spray for 1 attack. The primary end point was headache relief at 30 minutes, defined as reduction from moderate, severe, or very severe pain to no or mild pain. The study was approved by the appropriate ethics committees.

Results  Sixty-nine patients were available for an intention-to-treat analysis. The 30-minute headache relief rates were placebo, 21%; ZNS5, 40%; and ZNS10, 62%. Modeling the response as a binary outcome, the Wald test was significant for the overall regression (²₁ = 29.4; P<.001), with both ZNS5 and ZNS10 giving significant effects against placebo. Headache relief rates for patients with episodic cluster headache were 30% for placebo, 47% for ZNS5, and 80% for ZNS10, while corresponding rates for patients with chronic cluster headache were 14%, 28%, and 36%, respectively. Zolmitriptan was also well tolerated.

Conclusion  Five-milligram and 10-mg doses of zolmitriptan intranasal spray are effective within 30 minutes and well tolerated in the treatment of acute cluster headache.

Trial Registration  controlled-trials.com Identifier ISCRTN27362692.

Author Affiliations: Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, England (Drs Cittadini and Goadsby); Department of Neurology, University of Hamburg, Hamburg, Germany (Dr May); Department of Neurology, University of Munich, Munich, Germany (Dr Straube); Department of Neurology, University of Münster, Münster, Germany (Dr Evers); Department of Neurology, "C. Besta" Neurological Institute, Milan, Italy (Dr Bussone).

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