Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines

This study has been completed.
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
First received: July 20, 2005
Last updated: February 15, 2008
Last verified: February 2008
Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.

Condition Intervention Phase
Drug: dexamethasone 10mg IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Persistent headache pain free at 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain and disability scores at 2 and 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: July 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dexamethasone 10mg IV
  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Migraine with or without aura; probable migraine without aura

Exclusion Criteria:

  • Secondary headache
  • Allergy, contraindication or intolerance to study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122278

United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Columbia University Medical Center
Manhattan, New York, United States
St. Lukes Hospital
New York, New York, United States
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Benjamin W. Friedman, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

Responsible Party: Benjamin Friedman, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00122278     History of Changes
Other Study ID Numbers: MMC: 05-02-032S or CCI: 05-030 
Study First Received: July 20, 2005
Last Updated: February 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
migraine, emergency department, dexamethasone
Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016