Official Title: “Optimizing Discharge From the Emergency Department After Treatment for an Acute Primary Headache: A Randomized Trial of Sumatriptan Versus Naproxen for Recurrent Headache.”

2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2010

Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge.

To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively.

Specific aims:

1. To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED and which is more efficacious for the subset of headache patients with an acute migraine.

2. To determine the feasibility of grouping all primary headache disorder patients into one category for analysis.

Primary hypotheses:

1A. In the 48 hour period following ED treatment for migraine, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

1B. In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

2. Methodology hypothesis: When compared to those subjects with an acute migraine, "headache" patients who do not meet International Headache Society migraine criteria will demonstrate similar variability in response to treatment.

Intervention(s) in this Clinical Trial

• Drug: Sumatriptan 100mg
  • Sumatriptan 100mg po
• Drug: Naproxen
  • Naproxen 500mg po

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Sumatriptan
  • Sumatriptan 100mg po
• Active Comparator: Naproxen
  • Naproxen 500mg po

Primary Measures

• Pain intensity score
  • Time Frame: 48 hours after ED discharge
    Safety Issue?: No

Secondary Measures

• Adverse effects
  • Time Frame: 48 hours after ED discharge
    Safety Issue?: Yes
• Headache-related functional disability
  • Time Frame: 48 Hours after ED discharge
    Safety Issue?: No
• Patient satisfaction
  • Time Frame: 48 hours after ED discharge
    Safety Issue?: No

Inclusion Criteria:

• Treated in the emergency department for acute primary headache

Exclusion Criteria:

• Allergy, intolerance, or contra-indication to one of the study medications

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Montefiore Medical Center

Overall Clinical Trial Officials and Contacts

Benjamin W. Friedman, MD,MS Principal Investigator Albert Einstein College of Medicine of Yeshiva University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449787

Study ID Number: HEDNet2

ClinicalTrials.gov Identifier: NCT00449787

Health Authority: United States: Institutional Review Board