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Corticosteroids for Acute Migraine in the Emergency Department

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02847494
First received: July 25, 2016
Last updated: September 7, 2016
Last verified: July 2016
  Purpose
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.

Condition Intervention Phase
Migraine Drug: metoclopramide Drug: Dexamethasone Drug: methylprednisolone acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Headache days [ Time Frame: 1 week ]
    Number of days with headache during the week following emergency department discharge


Secondary Outcome Measures:
  • Sustained headache freedom [ Time Frame: 1 week ]
    No headache at all during the week following emergency department discharge

  • Preference [ Time Frame: 1 week ]
    Do you want to receive the same medication during a subsequent visit to the emergency department


Estimated Enrollment: 220
Study Start Date: September 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Metoclopramide 10mg IV+ dexamethasone 10mg IM
Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Drug: Dexamethasone
dexamethasone 10mg intramuscular injection
Active Comparator: Experimental
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
Drug: metoclopramide
metoclopramide 10mg intravenous infusion over 15 minutes
Drug: methylprednisolone acetate
methylprednislone acetate 160mg intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine without aura criteria (International Classification of Headache Disorders 3B )
  • Headache rated as moderate or severe in intensity

Exclusion Criteria:

  • Concern for secondary cause of headache
  • Contra-indications to investigational medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT02847494

Contacts
Contact: Belinda Tavarez 718-920-6626 btavarez@montefiore.org

Locations
United States, New York
Montefiore Medical Center--Einstein Recruiting
Bronx, New York, United States, 10461
Contact: Belinda Tavarez    718-920-6626    btavarez@montefiore.org   
Montefiore Medical Center-Moses Recruiting
Bronx, New York, United States, 10467
Contact: Belinda Tavarez       btavarez@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02847494     History of Changes
Other Study ID Numbers: 2016-6342
Study First Received: July 25, 2016
Last Updated: September 7, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Metoclopramide
Prednisolone hemisuccinate
Prednisolone 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

ClinicalTrials.gov processed this record on September 19, 2017