Skip to main content
. 2016 Apr 19;2016(4):CD005220. doi: 10.1002/14651858.CD005220.pub2

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Randomized (N = 66); withdrawn (N = 20); analyzed (N = 46)
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
  • Headache relief at 2 h

  • Pain free at 2 h

  • Presence of nausea,

  • Use of rescue medication

  • Adverse events

  • Recurrence of migraine within 2‐2h h


Other reported outcomes:
  • Headache relief, pain free, nausea, vomiting, photophobia, and phonophobia at 15, 30, and 60 min

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