Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Migraine Disorders

Treatments

Drug: Sumatriptan Succinate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00356603

STA106711

Details and patient eligibility

About

This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

Enrollment

75 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of migraine (with or without aura) or cluster headache according to the International Classification of Headache Disorders, Version 2 (ICHD-II)
History of migraine or cluster headache persisting for at least 6 months
Migraine: One to 6 attacks of moderate or severer headaches per month during the 2 months prior to enrollment
Cluster Headache: Each attack persisting for at least 45 minutes
Written informed consent obtained from the patient. When a patient is a minor, written informed consent from his/her proxy consenter (e.g., person with parental authority) will also be required.

Exclusion criteria

History of hypersensitivity to any of the ingredients of 5-HT1B/1D receptor antagonists (e.g., triptans) or serious AE due to treatment with these drugs
History of serious adverse event attributable to treatment with Imigran® Injection 3
History of myocardial infarction, current or previous history of ischemic heart disease or its symptoms/signs, or current history of atypical variant angina (coronary arteriospasm)
Previous history of cerebrovascular disorder or transient cerebral ischemic attack
Current or previous history of peripheral angiopathy (including Raynaud's syndrome)
Systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >95 mmHg at the start of treatment period
Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegic migraine
Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans
Pregnant women, lactating mothers, women who may be pregnant, or women of childbearing potential using no appropriate contraceptive measures.
Epilepsy or organic cerebral disorder which may lead to convulsion
Previous history of hypersensitivity to sulfonamides
Known drug allergy or idiosyncrasies
Known drug dependency or alcoholism