23 children aged 8.3 to 16.4 years who suffered at least 2
migraine headaches/month and who had not benefited from previous
medications were included in the study. They took both
sumitriptan and placebo in a randomized double-blind, placebo
controlled, cross-over trial.1
The sumitriptan dose was 50 mg for BSA approx. 0.75-1.5 m2
(6-12 y/o) and 100 mg for BSA > 1.5 m2 (>12
Each child treated migraine headache attack with sumitriptan
and one with placebo in random order.
The study excluded children with other medical problems or
those on chronic medications.
The main efficacy variable was headache severity. The
primary endpoint was a 50% or greater decrease in pain intensity
on a 100 mm visual analog scale at 2 hours.
Other endpoints of efficacy were 1) Pain Intensity Difference
(pain intensity before minus pain intensity at assessment),
essentially showing pain relief at each time point, 2) Summed
Pain Intensity Differences, an estimate of overall pain relief
during a time period, and 3) estimates of overall pain relief
Two hours after sumitriptan, 7 of 23 reached the primary endpoint
and after placebo 5 of 23, not statistically significant.
There was no difference in gender, age, stage of pubertal
development, or frequency of migraine headaches.
Within 2 hours, the headache disappeared completely in 5 of
23 children with sumitriptan and in 2 of 23 children with
placebo (not significant).
Median Pain Intensity Differences were slightly better for
sumitriptan between 0.5 and 4 hours (not significant).
Median Summed Pain Intensity Differences (SPID) increased
almost identically for up to 2 hours. Although median
SPIDs for placebo remained constant, with sumitriptan
they continued to improve. At 4 hours the median SPID
for sumitriptan was 2.4 times as high as placebo, still not
13 of 23 children preferred sumitriptan. 2 of 23 preferred
placebo. (p = 0.004).
Adverse events reported included vomiting, photophobia, nausea