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

NCT00963937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-08-06

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-28
Primary Completion
2010-12-01
Completion
2010-12-03

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963937 on ClinicalTrials.gov