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 |