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From the Institute of Neurology (Drs. Bahra and Goadsby), Queen Square, London, UK; Bayview Avenue (Dr. Gawel), North York, Ontario, Canada; Department of Neurology (Dr. Hardebo), Lund University Hospital, Gothenburg, Sweden; Department of Medicines Management (Dr. Millson), Keele University, Staffordshire, UK; and AstraZeneca (Drs. Millson and Breen), Alderley Park, Macclesfield, Cheshire, UK.
Address correspondence and reprint requests to Dr. Peter J. Goadsby, Institute of Neurology, Queen Square, London WC1N 3BG UK.
OBJECTIVE: To evaluate the efficacy and tolerability of oral zolmitriptan 5 mg and 10 mg and placebo in cluster headache.
METHODS: A multicenter, double-blind, randomized, three-period, crossover, outpatient study. Adult patients received placebo and zolmitriptan 5 mg and 10 mg orally for the acute treatment of episodic or chronic cluster headache. Headache intensity was rated by a five-point scale: none, mild, moderate, severe, or very severe. Patients only treated moderate to very severe headaches. The primary efficacy measure was headache response (two-point or greater reduction from baseline in the cluster headache rating scale) at 30 minutes. Secondary efficacy measures included proportion of patients with initial headache relief within 15 and 30 minutes, mild or no pain at 30 minutes, meaningful headache relief, and use of escape medication.
RESULTS: A total of 124 patients took at least one dose of study medication, with 73% having episodic and 27% chronic cluster headache. For the primary endpoint, there was a treatment-by-cluster-headache-type interaction (p = 0.0453). Therefore, results are presented separately for chronic and episodic cluster headache. In patients with episodic cluster headache, the difference between zolmitriptan 10 mg and placebo at 30 minutes reached significance (47% versus 29%; p = 0.02). Mild or no pain at 30 minutes was reported by 60%, 57%, and 42% patients treated with zolmitriptan 10 mg, zolmitriptan 5 mg, and placebo (both p 
0.01 versus placebo). For all other secondary endpoints, zolmitriptan 10 mg was significantly superior to placebo in episodic cluster headache patients, whereas zolmitriptan 5 mg was significantly superior to placebo for three of the four secondary endpoints. In patients with chronic cluster headache, response rates following zolmitriptan 5 mg or 10 mg were not significantly different from placebo at any endpoint. Zolmitriptan 5 mg and 10 mg were well tolerated.
CONCLUSION: Oral zolmitriptan is efficacious in episodic cluster headache.
Key words: Clinical trial—Cluster headache—Zolmitriptan—5-HT1B/1D receptor agonist
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