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

NCT ID: NCT00356603

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-20
• Study Completion Date: 2006-08-07

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.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sumatriptan

Sumatriptan

Group Type: EXPERIMENTAL

Sumatriptan Succinate

Intervention Type: DRUG

Sumatriptan Succinate

Interventions

Sumatriptan Succinate

Sumatriptan Succinate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Tokyo, , Japan

Countries

Japan

Other Identifiers

STA106711

Identifier Type: -

Identifier Source: org_study_id