Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399243
Status:
UNKNOWN
Last Update Posted:
2009-02-02
First Post:
2006-11-12
Brief Title:
Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache
Sponsor:
Diamond Headache Clinic
Organization:
Diamond Headache Clinic
Study Overview
Official Title:
4mg StatDose Imitrex for Acute Treatment of Cluster Headache
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This studys 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
Detailed Description:
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 5HT1B1D 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
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 5HT1B1D 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None