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 |
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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 |
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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 |
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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 |
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Notes | Results for primary outcome reported for episodic and chronic subgroups Oxford Quality Score: 4 (R1, DB2, W1) |
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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 |