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

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ClinicalTrials.gov Identifier: NCT00122278
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, 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 Other: Placebo Phase 3

  Show Detailed Description

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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

Arm Intervention/treatment
Experimental: Dexamethasone
Dexamethasone 10 mg
Drug: Dexamethasone
Dexamethasone 10mg IV
Other Name: Parental corticosteroid

Placebo Comparator: Placebo
Placebo Dexamethasone, 10 mg
Other: Placebo
Placebo Dexamethasone 10mg IV




Primary Outcome Measures :
  1. Persistent Headache Pain Free at 24 Hours [ Time Frame: 24 hours ]
    Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge


Secondary Outcome Measures :
  1. Functional Disability at 24 Hours [ Time Frame: 24 hours ]
    No functional impairment within 24 hours of emergency department discharge



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

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 ClinicalTrials.gov identifier (NCT number): NCT00122278


Locations
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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
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Principal Investigator: Benjamin W. Friedman, MD, MS Albert Einstein College of Medicine

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Responsible Party: Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00122278     History of Changes
Other Study ID Numbers: 05-02-032S
First Posted: July 22, 2005    Key Record Dates
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Benjamin W. Friedman, MD, 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:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action