Status:
COMPLETED
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Lead Sponsor:
GlaxoSmithKline
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00356603
Start Date
June 20 2006
End Date
August 7 2006
Last Update
September 4 2018
Active Locations (4)
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1
GSK Investigational Site
Aichi, Japan, 450-0002
2
GSK Investigational Site
Hyōgo, Japan, 663-8204
3
GSK Investigational Site
Kyoto, Japan, 600-8811
4
GSK Investigational Site
Tokyo, Japan, 105-7103