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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00356603 |
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 |
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Migraine Cluster Headache |
Drug: Sumatriptan Succinate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of Sumatriptan Succinate Injection Kit Product in Patients With Migraine or Cluster Headache |
Estimated 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) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Japan | |
GSK Investigational Site | |
Aichi, Japan, 450-0002 | |
GSK Investigational Site | |
Kyoto, Japan, 600-8811 | |
GSK Investigational Site | |
Hyogo, Japan, 663-8204 | |
GSK Investigational Site | |
Tokyo, Japan, 105-0021 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | STA106711 |
Study First Received: | July 25, 2006 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00356603 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Sumatriptan Succinate Injection Kit Migraine Cluster Headache self-injection |
Sumatriptan Cluster Headache Signs and Symptoms Migraine Disorders Headache Neurologic Manifestations |
Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Serotonin Headache Disorders |
Serotonin Agonists Neurotransmitter Agents Trigeminal Autonomic Cephalalgias Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |