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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.

Sponsors and Collaborators: Montefiore Medical Center
Albert Einstein College of Medicine of Yeshiva University
Information provided by: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00364806
  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 IV

Genetics Home Reference related topics:   familial hemiplegic migraine   

MedlinePlus related topics:   Headache    Migraine   

ChemIDplus related topics:   Metoclopramide    Metoclopramide hydrochloride    Prochlorperazine    Prochlorperazine edisylate    Prochlorperazine maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:   Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Yeshiva University

Investigators
Principal Investigator:     Benjamin W Friedman, MD, MS     Albert Einstein College of Medicine of Yeshiva University    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Montefiore Medical Center ( Benjamin friedman )
Study ID Numbers:   Migraine 3
First Received:   August 14, 2006
Last Updated:   May 19, 2008
ClinicalTrials.gov Identifier:   NCT00364806
Health Authority:   United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Migraine  
Headache  

Study placed in the following topic categories:
Prochlorperazine
Dopamine
Migraine Disorders
Headache
Central Nervous System Diseases
Emergencies
Headache Disorders, Primary
Brain Diseases
Metoclopramide
Headache Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease Attributes
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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