Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine; Cluster Headache
Intervention: Sumatriptan Succinate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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 the efficacy, and to examine patient acceptability (simplicity and usefulness)
and rate of successful self-injection.
Clinical Details
Official title: Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Headache Relief at 60 minutes Postdose(Migraine)
Headache Relief at 30 minutes Postdose(Cluster Headache)
Secondary outcome: Subject acceptability of the sumatriptan 3mg kit product
Rate of successful self-injection of the sumatriptan 3mg kit product
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
GSK Clinical Trials Call Center, Tokyo 105, Japan
GSK Clinical Trials Call Center, Nagoya 450, Japan
GSK Clinical Trials Call Center, Kyoto 600, Japan
GSK Clinical Trials Call Center, Nishinomiya City 663, Japan
Additional Information
Starting date: June 2006
Ending date: August 2006
Last updated: April 4, 2008
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