Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

PHASE3CompletedINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

September 28, 2009

Primary Completion Date

December 1, 2010

Study Completion Date

December 3, 2010

Conditions
Migraine Disorders
Interventions
DRUG

Sumatriptan 25 mg

One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.

DRUG

Sumatriptan 50 mg

Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.

DRUG

Placebo

Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.

Trial Locations (16)

450-0002

GSK Investigational Site, Aichi

467-8602

GSK Investigational Site, Aichi

060-0004

GSK Investigational Site, Hokkaido

060-8570

GSK Investigational Site, Hokkaido

658-0064

GSK Investigational Site, Hyōgo

663-8204

GSK Investigational Site, Hyōgo

892-0844

GSK Investigational Site, Kagoshima

215-0021

GSK Investigational Site, Kanagawa

221-0835

GSK Investigational Site, Kanagawa

252-0375

GSK Investigational Site, Kanagawa

600-8811

GSK Investigational Site, Kyoto

560-0012

GSK Investigational Site, Osaka

336-8522

GSK Investigational Site, Saitama

101-0021

GSK Investigational Site, Tokyo

105-7103

GSK Investigational Site, Tokyo

132-0024

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00963937 - Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents | Biotech Hunter | Biotech Hunter