PMID- 16492230
OWN - NLM
STAT- MEDLINE
DCOM- 20060901
LR  - 20131121
IS  - 0017-8748 (Print)
IS  - 0017-8748 (Linking)
VI  - 46
IP  - 2
DP  - 2006 Feb
TI  - Sumatriptan nasal spray in adolescent migraineurs: a randomized, double-blind, 
      placebo-controlled, acute study.
PG  - 212-22
AB  - OBJECTIVE: To compare the efficacy and tolerability of sumatriptan nasal spray 
      (NS) (5, 20 mg) versus placebo in the acute treatment of migraine in adolescent 
      subjects. BACKGROUND: Currently, no triptan is approved in the United States for 
      the treatment of migraine in adolescent subjects (12 to 17 years). In a previous 
      randomized, placebo-controlled study of 510 adolescent subjects, sumatriptan NS 
      at 5, 10, and 20 mg doses was well tolerated. However, the primary efficacy 
      analysis for headache relief with 20 mg at 2 hours did not demonstrate 
      statistical significance (P = .059). A second study was initiated to evaluate the 
      efficacy of sumatriptan NS in this population. METHODS: This was a randomized 
      (1:1:1), placebo-controlled, double-blind, parallel-group study. Overall, 738 
      adolescent subjects (mean age: 14 years) with > or = 6-month history of migraine 
      (with or without aura) self-treated a single attack of moderate or severe 
      migraine. The primary endpoints were headache relief at 1 hour and sustained 
      relief from 1 to 24 hours. Pain-free rates, presence/absence of associated 
      symptoms, headache recurrence, and use of rescue medications were also assessed. 
      Tolerability was based on adverse events (AEs) and vital signs. RESULTS: 
      Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes 
      (42% vs. 33%, respectively; P = .046) and 2 hours (68% vs. 58%; P = .025) 
      postdose, but did not reach statistical significance at 1 hour (61% vs. 52%; P = 
      .087) or for sustained headache relief from 1 to 24 hours (P = .061). Significant 
      differences (P < .05) in favor of sumatriptan NS 20 mg over placebo were observed 
      for several secondary efficacy endpoints including sustained relief from 2 to 24 
      hours. In general, sumatriptan NS 5 mg percentages were slightly higher than 
      placebo but the differences did not reach statistical significance. Both doses of 
      sumatriptan NS were well tolerated. No AEs were serious or led to study 
      withdrawal. The most common event was taste disturbance (2%, placebo; 19%, 
      sumatriptan NS 5 mg; 25%, sumatriptan NS 20 mg). CONCLUSIONS: This study suggests 
      that sumatriptan may be beneficial to some adolescents and is generally well 
      tolerated in the acute treatment of migraine in this population.
FAU - Winner, Paul
AU  - Winner P
AD  - Palm Beach Headache Center, West Palm Beach, FL 33407, USA.
FAU - Rothner, A David
AU  - Rothner AD
FAU - Wooten, John D
AU  - Wooten JD
FAU - Webster, Chris
AU  - Webster C
FAU - Ames, Michael
AU  - Ames M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Headache
JT  - Headache
JID - 2985091R
RN  - 0 (Serotonin Receptor Agonists)
RN  - 8R78F6L9VO (Sumatriptan)
SB  - IM
CIN - Headache. 2006 Feb;46(2):195-6. PMID: 16492226
MH  - Acute Disease
MH  - Administration, Inhalation
MH  - Administration, Intranasal
MH  - Adolescent
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Humans
MH  - Migraine Disorders/*drug therapy
MH  - Nausea/chemically induced
MH  - Serotonin Receptor Agonists/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Sumatriptan/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Vomiting/chemically induced
EDAT- 2006/02/24 09:00
MHDA- 2006/09/02 09:00
CRDT- 2006/02/24 09:00
PHST- 2006/02/24 09:00 [pubmed]
PHST- 2006/09/02 09:00 [medline]
PHST- 2006/02/24 09:00 [entrez]
AID - HED339 [pii]
AID - 10.1111/j.1526-4610.2006.00339.x [doi]
PST - ppublish
SO  - Headache. 2006 Feb;46(2):212-22. doi: 10.1111/j.1526-4610.2006.00339.x.