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