CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 178 enrolled
Drug / intervention
Sumatriptan 25 mg +2 moredrug
Likely dose
Sumatriptan 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00963937
NCT00963937Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Aug 24, 2009·Updated Aug 6, 2018

In Brief

A Phase 3 clinical trial evaluating Sumatriptan 25 mg, Sumatriptan 50 mg, and 1 other intervention for Migraine Disorders. Completed, enrolled 178 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2009
Enrollment StartSep 28, 2009
Primary CompletionDec 1, 2010
Study CompletionDec 3, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.9 years ago

Interventions

Sumatriptan 25 mgdrug

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.

Sumatriptan 50 mgdrug

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.

Placebodrug

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.