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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122278
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : February 18, 2008
Information provided by:
Montefiore Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Drug: dexamethasone 10mg IV Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches
Study Start Date : July 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Intervention Details:
    Drug: dexamethasone 10mg IV

Primary Outcome Measures :
  1. Persistent headache pain free at 24 hours [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pain and disability scores at 2 and 24 hours [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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, Inc.

Responsible Party: Benjamin Friedman, Albert Einstein College of Medicine Identifier: NCT00122278     History of Changes
Other Study ID Numbers: MMC: 05-02-032S or CCI: 05-030
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008

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
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action