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 Research & Development Ltd0 sites178 target enrollmentDecember 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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:

•\- 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.