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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00399243
Other study ID # DHC08
Secondary ID
Status Unknown status
Phase Phase 4
First received November 12, 2006
Last updated January 29, 2009
Start date November 2006
Est. completion date August 2010

Study information

Verified date January 2009
Source Diamond Headache Clinic
Contact Fred G Freitag, DO
Phone 773 388 6390
Email research@diamondheadache.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
United States Diamond Headache Clinic Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Diamond Headache Clinic GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary The time meaningful relief of cluster headache. Meaningful Relief
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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. 15 minutes and 30 minutes
Secondary 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. 15 minutes, 30 minutes, and 1 hour
Secondary Patient evaluation of subcutaneous sumatriptan 4 mg regarding satisfaction with their treatment using the PPMQR assessment. End of treatment
Secondary 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. Length of study
Secondary 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. 1 hour
Secondary The percentage of cluster headaches in which the patient became free at or before 1 hour and experienced a recurrence of cluster headache. 1 hour
Secondary The mean time to meaningful pain relief across three treated headache attacks. Length of study
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