Methods | Participants recruited from 33 international neurology centres; in-patient based study R, DB, three-period cross-over study; 18 h washout One headache episode treated with each of two treatments |
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Participants | IHS diagnosis of cluster headache N = 157 randomised, 134 in efficacy analysis Mean age 41 ± 9 years 87% men Headache type: 72% episodic |
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Interventions | Sumatriptan 6 mg, subcutaneous, n = 92 Sumatriptan 12 mg, subcutaneous, n = 88 Placebo, n = 88 Patients received 0.5 mL injection within 10 min of headache episode of at least moderate intensity Rescue medication permitted after 15 min |
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Outcomes | Primary: Pain relief to mild or none at 10 min on a five-point scale Secondary: Headache relief at 5 and 15 min; pain-free at 15 min; associated symptoms; overall functional disability; adverse events/withdrawals; use of rescue medication |
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Notes | Oxford Quality Score: 4 (R2, DB1, W1) | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Generated by computer |
Allocation concealment? | Unclear | Not described |
Blinding? All outcomes |
Unclear | Not described |