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

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00122278
First received: July 20, 2005
Last updated: February 15, 2008
Last verified: February 2008
History of Changes
  Purpose

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
Migraine
 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:

U.S. FDA Resources

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
    corticosteroid
  Show Detailed Description

  Eligibility

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

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

Locations
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
Investigators
Principal Investigator: Benjamin W. Friedman, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

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:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
 Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013