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Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents | Clinical Trials | Clareo Health

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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

NCT00963937•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is \>10 years of age and \<17 years of age at the informed consent and the Randomization Visit.
•Subject has migraine with or without aura (ICHD-II criteria, 1.1 or 1.2.1). A minimum of a six month history of migraine prior to entry into the study is required.
•Subject has a history of at least two, but no more than eight, attacks per month for the two months prior to entry into the study.
•All migraine attacks associated with 3 or more pain on a 5-grade scale should last a minimum of three hours for the two months prior to entry into the study.
•Subject has shown nonresponse to at least one NSAIDs or acetaminophen for the two months prior to entry into the study.
•Subject is able to distinguish migraine from other headaches (e.g., tension-type headache).
•Subject is able to read, comprehend, and complete subject diaries.
•Males or female subjects. Female subjects are eligible for participation in the study if they are one of the following
•Females of non-childbearing potential (i.e., physiologically incapable of becoming pregnant or have undergone female sterilization)
•Females of childbearing potential, and who have a negative pregnancy test at the Screening Visit, and agree to use one of the following GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy:
+9 more criteria

Exclusion Criteria

•Subject is \< 30 kg.
•Subject has 15 or more headache days per month in total (migraine, probable migraine, or tension-type). Subject has retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), hemiplegic (ICHD-II 1.2.4 or 1.2.5), or Ophthalmoplegic migraine (ICHD-II 13.17). Subject has secondary headaches.
•Subject has a history of cerebrovascular disease or ischemic cerebrovascular disease.
•Subject has a history of myocardial infarction.
•Subject has uncontrolled hypertension.
•Subject has symptoms or signs of ischemic cardiac syndromes.
•Subject has variant angina.
•Subject has evidence of a peripheral vascular syndrome.
•Subject has evidence or history of epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control.
•Subject has a history of impaired hepatic or renal function that, in the investigator (or subinvestigator)'s opinion, contraindicates participation in this study. Subject has unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice). Subject has cirrhosis. Subject has known biliary abnormalities (with the exception of Gilberts's syndrome or asymptomatic gallstones).
+6 more criteria

Locations (16)

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

Key Dates

Start Date

September 28, 2009

Primary Completion Date

December 1, 2010

Completion Date

December 3, 2010

Last Updated

August 6, 2018

Enrollment

178

ACTUAL participants

Conditions

Migraine Disorders

Interventions

Sumatriptan 25 mg

DRUG

Sumatriptan 50 mg

DRUG

Placebo

DRUG

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

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RECRUITING

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

NCT05570149

Migraine Disorders

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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