Skip to main content
. 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 five international study centres; out-patient based
R, DB, three-period cross-over; 24 h washout
One headache episode treated for each treatment
Participants Established IHS diagnosis of cluster headache
N = 92 randomised, 69 took ≥ 1 medication
Mean age 40 ±10 years
87% men
Headache type: 64% episodic
Interventions Zolmitriptan 5 mg, nasal spray, n = 65
Zolmitriptan 10 mg, nasal spray, n = 63
Placebo, n = 61
Patients instructed to take medication when headache reached 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: 4 (R1, DB2, W1)
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Not described
Allocation concealment? Yes Randomization schedule provided by sponsor and kept by pharmacies until study completed
Blinding?
All outcomes
Yes Matching placebo