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:

Collaborator:

Albert Einstein College of Medicine, Inc.

Information provided by:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT00364806

First received: August 14, 2006

Last updated: May 19, 2008

Last verified: May 2008

History of Changes

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-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:

MedlinePlus related topics: Migraine

Drug Information available for: Prochlorperazine Prochlorperazine maleate Metoclopramide Prochlorperazine edisylate Metoclopramide hydrochloride

U.S. FDA Resources

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 (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

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: 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
Study First Received:	August 14, 2006
Last Updated:	May 19, 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

ClinicalTrials.gov processed this record on July 18, 2017

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