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

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