Corticosteroids for Acute Migraine in the Emergency Department
NCT ID: NCT02847494
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2016-09-01
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control
Metoclopramide 10mg IV+ dexamethasone 10mg IM
metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Dexamethasone
dexamethasone 10mg intramuscular injection
Experimental
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection
Interventions
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metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Dexamethasone
dexamethasone 10mg intramuscular injection
methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Headache rated as moderate or severe in intensity
Exclusion Criteria
* Contra-indications to investigational medications
18 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Benjamin W. Friedman, MD
PI
Principal Investigators
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Benjamin W Friedman, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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Montefiore Medical Center--Einstein
The Bronx, New York, United States
Montefiore Medical Center-Moses
The Bronx, New York, United States
Countries
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References
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Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-6342
Identifier Type: -
Identifier Source: org_study_id
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