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Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00356603
First received: July 25, 2006
Last updated: May 13, 2013
Last verified: May 2013
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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 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
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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
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
| 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 |
Keywords provided by GlaxoSmithKline:
|
Migraine Sumatriptan Succinate Injection Kit Cluster Headache self-injection |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Cluster Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations |
Signs and Symptoms Trigeminal Autonomic Cephalalgias Sumatriptan Vasoconstrictor Agents 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 July 18, 2017