Clinical trial NCT00356603: Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Official title: Imigran STATdose - Japan Clinical Experience Study for Self-injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: Migraine
Sumatriptan Succinate Injection Kit
Cluster Headache
self-injection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache)
timeFrame: 30 minutes or 60 Minutes after each administration
Secondary outcomes:
measure: Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product
timeFrame: Up to 2 months
measure: Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: