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

Imigran STATdose - Japan Clinical Experience Study for Self-injection


Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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 the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

Overall Status Completed
Start Date 2006-06-20
Completion Date 2006-08-07
Primary Completion Date 2006-08-07
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) 30 minutes or 60 Minutes after each administration
Secondary Outcome
Measure Time Frame
Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product Up to 2 months
Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate Up to 2 months
Enrollment 75

Intervention Type: Drug

Intervention Name: Sumatriptan Succinate

Description: Sumatriptan Succinate

Arm Group Label: Sumatriptan



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



Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:


Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
GSK Investigational Site | Aichi, 450-0002, Japan
GSK Investigational Site | Hyogo, 663-8204, Japan
GSK Investigational Site | Kyoto, 600-8811, Japan
GSK Investigational Site | Tokyo, 105-7103, Japan
Location Countries


Verification Date


Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Sumatriptan

Type: Experimental

Description: Sumatriptan

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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