Official Title: “Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2006

Intervention(s) in this Clinical Trial

• Drug: Sumatriptan Succinate

Primary Measures

• Headache Relief at 60 minutes Postdose(Migraine) Headache Relief at 30 minutes Postdose(Cluster Headache)
  • Time Frame: 60 Minutes
    

Secondary Measures

• Subject acceptability of the sumatriptan 3mg kit product Rate of successful self-injection of the sumatriptan 3mg kit product

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356603

Study ID Number: STA106711

ClinicalTrials.gov Identifier: NCT00356603

Health Authority: Japan: Ministry of Health, Labor and Welfare