Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache
4mg StatDose Imitrex for Acute Treatment of Cluster Headache
4mg StatDose Imitrex for Acute Treatment of Cluster Headache
Sponsor study identifier
interventional
20
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
November 12, 2006
Actual (reported)November 14, 2006
Actual (reported)August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
15 minutes and 30 minutes
The time meaningful relief of cluster headache.
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.
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.
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.
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.
15 minutes and 30 minutes
4mg Sumatriptan Statdose injection for use as acute therapy in a cluster headache. Consistency of response in three attacks will be measured
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Diamond Headache Clinic
Chicago, Illinois, 60614, United States
Seymour Diamond, MD
Diamond Headache Clinic
First Submitted
November 12, 2006
First Posted
November 14, 2006
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Estimated (date passed)Efficacy and Safety of Zolmitriptan by Sublingual Administration
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 2, 2009
Record last verified: 2009-01
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Source: ClinicalTrials.gov.
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