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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364806
First Posted: August 16, 2006
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Albert Einstein College of Medicine, Inc.
Information provided by:
Montefiore Medical Center
  Purpose
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
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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364806


Locations
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.
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Benjamin friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00364806     History of Changes
Other Study ID Numbers: Migraine 3
First Submitted: August 14, 2006
First Posted: August 16, 2006
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Montefiore Medical Center:
Migraine
Headache

Additional relevant MeSH terms:
Emergencies
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metoclopramide
Prochlorperazine
Antiemetics
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


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