PMID- 24163282
OWN - NLM
STAT- MEDLINE
DCOM- 20141118
LR  - 20140331
IS  - 1468-2982 (Electronic)
IS  - 0333-1024 (Linking)
VI  - 34
IP  - 5
DP  - 2014 Apr
TI  - Oral sumatriptan for migraine in children and adolescents: a randomized, 
      multicenter, placebo-controlled, parallel group study.
PG  - 365-75
LID - 10.1177/0333102413510213 [doi]
AB  - OBJECTIVE: The objective of this article is to evaluate the efficacy and 
      tolerability of two doses of oral sumatriptan vs placebo in the acute treatment 
      of migraine in children and adolescents. BACKGROUND: Currently, there is no 
      approved prescription medication in Japan for the treatment of migraine in 
      children and adolescents. METHODS: This was a multicenter, outpatient, 
      single-attack, double-blind, randomized, placebo-controlled, parallel-group 
      study. Eligible patients were children and adolescents aged 10 to 17 years 
      diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 
      17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo 
      (1:1:2). The primary efficacy endpoint was headache relief by two grades on a 
      five-grade scale at two hours post-dose. RESULTS: A total of 178 patients from 17 
      centers in Japan were enrolled and randomized to an investigational product in 
      double-blind fashion. Of these, 144 patients self-treated a single migraine 
      attack, and all provided a post-dose efficacy assessment and completed the study. 
      The percentage of patients in the full analysis set (FAS) population who report 
      pain relief at two hours post-treatment for the primary endpoint was higher in 
      the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: 
      -23.02 to 8.04, P  = 0.345). The percentage of patients in the FAS population who 
      reported pain relief at four hours post-dose was higher in the pooled sumatriptan 
      group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical 
      significance ( P  = 0.142). At four hours post-dose, percentages of patients who 
      were pain free or had complete relief of photophobia or phonophobia were 
      numerically higher in the sumatriptan pooled group compared to placebo. Both 
      doses of oral sumatriptan were well tolerated. No adverse events (AEs) were 
      serious or led to study withdrawal. The most common AEs were somnolence in 6% 
      (two patients) in the sumatriptan 25 mg treatment group and chest discomfort in 
      7% (three patients) in the sumatriptan 50 mg treatment group. CONCLUSIONS: There 
      was no statistically significant improvement between the sumatriptan pooled group 
      and the placebo group for pain relief at two hours. Oral sumatriptan was well 
      tolerated.
FAU - Fujita, Mitsue
AU  - Fujita M
AD  - Tsukuba Gakuen Hospital, Japan.
FAU - Sato, Katsuaki
AU  - Sato K
FAU - Nishioka, Hiroshi
AU  - Nishioka H
FAU - Sakai, Fumihiko
AU  - Sakai F
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131025
PL  - England
TA  - Cephalalgia
JT  - Cephalalgia : an international journal of headache
JID - 8200710
RN  - 0 (Vasoconstrictor Agents)
RN  - 8R78F6L9VO (Sumatriptan)
SB  - IM
CIN - Cephalalgia. 2014 Apr;34(5):325-6. PMID: 24163281
MH  - Administration, Oral
MH  - Adolescent
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Migraine Disorders/*drug therapy
MH  - Sumatriptan/*administration & dosage/adverse effects
MH  - Vasoconstrictor Agents/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - Sumatriptan
OT  - adolescents
OT  - children
OT  - migraine
EDAT- 2013/10/29 06:00
MHDA- 2014/11/19 06:00
CRDT- 2013/10/29 06:00
PHST- 2013/10/29 06:00 [entrez]
PHST- 2013/10/29 06:00 [pubmed]
PHST- 2014/11/19 06:00 [medline]
AID - 0333102413510213 [pii]
AID - 10.1177/0333102413510213 [doi]
PST - ppublish
SO  - Cephalalgia. 2014 Apr;34(5):365-75. doi: 10.1177/0333102413510213. Epub 2013 Oct 
      25.