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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:
Montefiore Medical Center
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00122278
First received: July 20, 2005
Last updated: February 15, 2008
Last verified: February 2008
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 ]
Secondary Outcome Measures:
- Pain and disability scores at 2 and 24 hours [ Time Frame: 24 hours ]
| 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 (Adult, Senior) |
| 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
Contacts and Locations
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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
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, Inc. |
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 |
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 Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate 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 |
ClinicalTrials.gov processed this record on July 18, 2017