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Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache

NCT00399243 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-02-02

No results posted yet for this study

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.

Conditions

  • Episodic Cluster Headache
  • Chronic Cluster Headache

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Seymour Diamond, MD · Diamond Headache Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399243 on ClinicalTrials.gov