Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
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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.
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) [ Time Frame: 30 minutes or 60 Minutes after each administration ]
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
Secondary Outcome Measures
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product [ Time Frame: Up to 2 months ]
The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented.
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate [ Time Frame: Up to 2 months ]
The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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