A Randomized Trial to Optimize Discharge From the ED After Treatment for Headache
Information source: Montefiore Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine; Tension-Type Headache; Primary Headache Disorder
Intervention: Sumatriptan 100mg (Drug); Naproxen (Drug)
Phase: Phase 4
Sponsored by: Montefiore Medical Center
Official(s) and/or principal investigator(s):
Benjamin W. Friedman, MD,MS, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
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.
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain intensity score
Headache-related functional disability
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.
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.
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
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- Treated in the emergency department for acute primary headache
- Allergy, intolerance, or contra-indication to one of the study medications
Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Benjamin W. Friedman, MD, MS, Email: email@example.com
Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Niels M Dua, MD, Email: firstname.lastname@example.org
Starting date: March 2007
Ending date: February 2010
Last updated: February 14, 2009