Callenbach 2007.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, cross‐over, 2‐attack study of sumatriptan nasal spray | |
Participants | Participants from 18 centres in the Netherlands were 12‐17 years of age with a diagnosis of migraine with or without aura per revised IHS 1988 criteria (Winner 1995) whom had failed, or responded inadequately, to at least 1 over the counter or prescription medication for migraine, duration typically longer than 4 hours if untreated, and between 1 and 8 attacks per month in each of the 2 months before enrolment Randomized (N = 66); withdrawn (N = 20); analyzed (N = 46) |
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Interventions | Each participant treated 2 attacks ‐ 1 with sumatriptan nasal spray (10 mg if < 40 kg or 20 mg if > 40 kg) and 1 with placebo nasal spray. Recurrence within 2‐24 h could be treated with a second dose. | |
Outcomes |
Other reported outcomes:
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Headache severity scale | 4‐point scale (none, mild, moderate, severe) | |
Funding source | GlaxoSmithKline | |
Publication | Journal and Clinical Trial Registry | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "in a randomized order" Comment: other studies funded by GlaxoSmithKline reported acceptable sequence generation (e.g. Winner 2007) |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: withdrawals balanced across intervention groups |
Selective reporting (reporting bias) | Low risk | Comment: all expected outcomes reported |