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 theInternational 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 2months 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, writteninformed 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 receptorantagonists (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 heartdisease or its symptoms/signs, or current history of atypical variant angina (coronaryarteriospasm)

• 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 atthe start of treatment period

• Current familial hemiplegic migraine, basilar migraine, or sporadic hemiplegicmigraine

• Current abuse of ergotamine- or dihydroergotamine-containing preparations or triptans

• Pregnant women, lactating mothers, women who may be pregnant, or women of childbearingpotential 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