NCT00399243

Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

4mg StatDose Imitrex for Acute Treatment of Cluster Headache

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Diamond Headache Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

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 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.

Conditions

• Episodic Cluster Headache
• Chronic Cluster Headache

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2006-11-14
• Last updated: 2009-02-02

Locations

1 site across 1 country: United States