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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008042. doi: 10.1002/14651858.CD008042.pub2
Methods Participants recruited from neurology departments; 13 international centres; out-patient based
R, DB, three-period cross-over; 20 h washout
One headache episode treated for each treatment
Participants IHS diagnosis of cluster headache for at least three months; able to recognise an attack; excluded if taking any other medications to treat or prevent headache
N = 153 randomised, 124 took ≥1 medication, 123 in efficacy analysis
Mean age 44 ± 11 years
86% men
Headache type: 73% episodic
Interventions Zolmitriptan 5 mg, oral, n = 114
Zolmitriptan 10 mg, oral, n = 111
Placebo, n = 115
Patients instructed to take single dose of trial medication within 10 min of onset if headache was of at least moderate intensity
Escape medication permitted after 30 min
Outcomes Primary: Pain relief to mild or none at 30 min on a five-point scale
Secondary: Pain-free at 30 min; relief of associated symptoms; adverse events/withdrawals; use of rescue medication
Notes Results for primary outcome reported for episodic and chronic subgroups
Oxford Quality Score: 5 (R2, DB2, W1)
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Computer-generated randomisation sequence
Allocation concealment? Unclear Not described
Blinding?
All outcomes
Yes Colour-matched placebo tablets. Four tablets taken in appropriate combination of zolmitriptan 2.5 mg and placebo