Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache
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|ClinicalTrials.gov Identifier: NCT00399243|
Recruitment Status : Unknown
Verified January 2009 by Diamond Headache Clinic.
Recruitment status was: Recruiting
First Posted : November 14, 2006
Last Update Posted : February 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Episodic Cluster Headache Chronic Cluster Headache||Drug: Sumatriptan 4mg Statdose injection||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||4mg StatDose Imitrex for Acute Treatment of Cluster Headache|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||August 2010|
- Drug: Sumatriptan 4mg Statdose injection
4mg Sumatriptan Statdose injection for use as acute therapy in a cluster headache. Consistency of response in three attacks will be measured
- The primary efficacy parameters will be the percentage of cluster headache attacks that result in the cluster headache pain being reduced to mild or none following a single dose of 4 mg subcutaneous sumatriptan at 15 minutes and at 30 minutes. [ Time Frame: 15 minutes and 30 minutes ]
- The time meaningful relief of cluster headache. [ Time Frame: Meaningful Relief ]
- The percentage of attacks that produce a pain free response to a single dose of sumatriptan 4 mg subcutaneous at 15 minutes, 30 minutes and at 1 hour. [ Time Frame: 30 minutes and 1 Hour ]
- The percentage of attacks of migraine that result in resolution of all associated symptoms of cluster headache present at the time of treatment with the study medication as well as achieving a pain free response within 1hour. [ Time Frame: 1 hour ]
- The number of patients reporting adverse effects to study medication, the type of adverse event reported and the percentage of attacks that are associate with the adverse effect. [ Time Frame: Length of study ]
- The percentage of patients who achieve pain reduced to mild or none at 15 minutes or at 30 minutes respectively for all three treated headache attacks. [ Time Frame: 15 minutes and 30 minutes ]
- The percentage of patients who achieve pain reduced to mild or none at 15 minutes or at 30 minutes respectively for two out of three treated headaches. [ Time Frame: 15 minutes and 30 minutes ]
- The percentage of patients who become pain free at 15 minutes or 30 minutes or at 1 hour respectively or at any combination of the three time points for all three headache attacks. [ Time Frame: 15 minutes, 30 minutes, and 1 hour ]
- Patient evaluation of subcutaneous sumatriptan 4 mg regarding satisfaction with their treatment using the PPMQR assessment. [ Time Frame: End of treatment ]
- The percentage of attacks in which the pain was reduced to moderate or mild and for which the patient took a second and or a third dose of the study medication. [ Time Frame: Length of study ]
- The percentage of attacks in which the patient became pain free at or before 1 hour and experienced a recurrence of cluster headache and in which a second or third dose of study medication was taken. [ Time Frame: 1 hour ]
- The percentage of cluster headaches in which the patient became free at or before 1 hour and experienced a recurrence of cluster headache. [ Time Frame: 1 hour ]
- The mean time to meaningful pain relief across three treated headache attacks. [ Time Frame: Length of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399243
|Contact: Fred G Freitag, DO||773 388 firstname.lastname@example.org|
|Contact: George Nissan, DO||773 388 email@example.com|
|United States, Illinois|
|Diamond Headache Clinic||Recruiting|
|Chicago, Illinois, United States, 60614|
|Contact: Nancy Caldwell, RN 773-388-6390 firstname.lastname@example.org|
|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|