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A Clinical Trial Comparing Two Different Medications to Determine Which One is Better for Patients With an Acute Migraines in the Emergency Department

This study has been completed.
Albert Einstein College of Medicine, Inc.
Information provided by:
Montefiore Medical Center Identifier:
First received: August 14, 2006
Last updated: May 19, 2008
Last verified: May 2008
Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.

Condition Intervention Phase
Migraine Drug: Prochlorperazine Drug: Metoclopramide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • One hour pain scores

Secondary Outcome Measures:
  • One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.

Estimated Enrollment: 76
Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

One-third of the five million headache patients who present to US Emergency Departments (ED) annually have a migraine headache. The anti-emetic dopamine receptor antagonists have proven efficacy for migraines, are at least as well-tolerated as triptans, and enjoy wide-spread use in North American EDs. However, it is not yet clear which medication within this class and which dosage is optimal. Therefore, we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine.

Specific Aim: To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches. Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects.

Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate. Medications will be administered as an intravenous drip over 15 minutes. Rescue medication will be administered, if needed, after one hour. A follow-up phone call will be conducted 24 hours after the ED visit.


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

Inclusion Criteria:

  • Present to the Ed with an acute migraine headache

Exclusion Criteria:

  • secondary headache
  • if the patient is to receive a lumbar puncture in the ED
  • maximum temperature greater than 100.3 degrees
  • new objective neurologic abnormality at the time of physical exam
  • allergy or intolerance to a study medication
  • pregnancy
  • previous enrollment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00364806

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine, Inc.
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Benjamin friedman, Montefiore Medical Center Identifier: NCT00364806     History of Changes
Other Study ID Numbers: Migraine 3
Study First Received: August 14, 2006
Last Updated: May 19, 2008

Keywords provided by Montefiore Medical Center:

Additional relevant MeSH terms:
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on July 21, 2017