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Sponsored by: |
Montefiore Medical Center |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00122278 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Benjamin W. Friedman, MD, MS | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Albert Einstein College of Medicine ( Benjamin Friedman ) |
Study ID Numbers: | MMC: 05-02-032S or CCI: 05-030 |
Study First Received: | July 20, 2005 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00122278 |
Health Authority: | United States: Institutional Review Board |
migraine, emergency department, dexamethasone Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition |
Dexamethasone Migraine Disorders Headache Central Nervous System Diseases Emergencies |
Headache Disorders, Primary Brain Diseases Dexamethasone acetate Headache Disorders Migraine without Aura |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |