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Sponsors and Collaborators: |
Diamond Headache Clinic GlaxoSmithKline |
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Information provided by: | Diamond Headache Clinic |
ClinicalTrials.gov Identifier: | NCT00399243 |
This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment of cluster headache and provides good safety and tolerability across multiple doses of the study medication as well as across multiple attacks of cluster headache. This study seeks to determine the safety and efficacy of the commercially available 4mg StatDose formulation of sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated dose of the study medication for a given headache if they have had a partial response to the first dose. They may treat up to 3 attacks of cluster headache with the study medication. Safety assessment will be through adverse event reporting and physical examination. Patients with both episodic cluster headache as well as chronic cluster headache will be studied. Patients must either not have started preventive treatment for cluster headache or be on a stable dose of preventive medication.
Condition | Intervention | Phase |
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Episodic Cluster Headache Chronic Cluster Headache |
Drug: Sumatriptan 4mg Statdose injection |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 4mg StatDose Imitrex for Acute Treatment of Cluster Headache |
Estimated Enrollment: | 20 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
This is an open label trial of sumatriptan 4 mg using the StatDose injector system for the treatment of acute attacks of cluster headache.
Patient entering the trial must either be in the first 3 weeks of an episodic cluster headache cycle or have chronic cluster headache. Patients with episodic cluster headache may have not begun taking preventive medications at the time of study or must be on a stable regimen of preventive medications.
Patients with chronic cluster headache must be on a stable regimen of preventive medications.
Patients must be in good health with no contraindications to the use of sumatriptan such as either having or having increased risk factors for CAD or CVD. They may not take during the time of the study preventive medications that are 5HT1B/1D agonists. Episodic use of triptans, ergotamine, or dihydroergotamine is permitted provided they are not used within 24 hours of use of the study medication.
Patients will be required to treat 3 acute attacks of cluster headache with the study medication or to use more than 1 dose of study medication to fully treat an individual attack of cluster headache with a maximum of 3 doses of the study medication within a 24 hour time frame.
Efficacy of the study medication will be determined from diary data collected. Safety data will be determined by adverse events reported by the patient.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fred G Freitag, DO | 773 388 6390 | research@diamondheadache.com |
Contact: George Nissan, DO | 773 388 6390 | research@diamondheadache.com |
United States, Illinois | |
Diamond Headache Clinic | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: Nancy Caldwell, RN 773-388-6390 ncaldwell@diamondheadache.com | |
Sub-Investigator: Fred G Freitag, DO | |
Sub-Investigator: George Nissan, DO | |
Sub-Investigator: Merle Diamond, MD | |
Sub-Investigator: George Urban, MD | |
Sub-Investigator: Betsy Pepper, MD |
Principal Investigator: | Seymour Diamond, MD | Diamond Headache Clinic |
Responsible Party: | Diamond Headache Clinic ( Frederick Freitag, D.O. ) |
Study ID Numbers: | DHC08 |
Study First Received: | November 12, 2006 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00399243 History of Changes |
Health Authority: | United States: Institutional Review Board |
cluster headache sumatriptan |
Serotonin Agonists Cluster Headache Neurotransmitter Agents Central Nervous System Diseases Headache Disorders, Primary Pain Cardiovascular Agents Brain Diseases |
Serotonin Headache Disorders Sumatriptan Signs and Symptoms Headache Vasoconstrictor Agents Neurologic Manifestations Cluster Headaches |
Serotonin Agonists Cluster Headache Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Pain Cardiovascular Agents Brain Diseases |
Pharmacologic Actions Headache Disorders Sumatriptan Signs and Symptoms Trigeminal Autonomic Cephalalgias Serotonin Agents Therapeutic Uses Headache Vasoconstrictor Agents Neurologic Manifestations |