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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356603
First received: July 25, 2006
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Cluster Headache
Migraine
Drug: Sumatriptan Succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Headache Relief at 60 minutes Postdose(Migraine) Headache Relief at 30 minutes Postdose(Cluster Headache) [ Time Frame: 60 Minutes ]

Secondary Outcome Measures:
  • Subject acceptability of the sumatriptan 3mg kit product Rate of successful self-injection of the sumatriptan 3mg kit product

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sumatriptan Succinate
    Other Name: Sumatriptan Succinate
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356603

Locations
Japan
GSK Investigational Site
Aichi, Japan, 450-0002
GSK Investigational Site
Hyogo, Japan, 663-8204
GSK Investigational Site
Kyoto, Japan, 600-8811
GSK Investigational Site
Tokyo, Japan, 105-7103
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00356603     History of Changes
Other Study ID Numbers: STA106711
Study First Received: July 25, 2006
Last Updated: May 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Migraine
Sumatriptan Succinate Injection Kit
Cluster Headache
self-injection

Additional relevant MeSH terms:
Headache
Migraine Disorders
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Trigeminal Autonomic Cephalalgias
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014