NCT00963937

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

A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-28
• Primary completion: 2010-12-01
• Completion: 2010-12-03
• First posted: 2009-08-24
• Last updated: 2018-08-06
• Results posted: 2011-08-26

Locations

16 sites across 1 country: Japan