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 of Yeshiva University
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00364806
First received: August 14, 2006
Last updated: May 19, 2008
Last verified: May 2008
  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
Endpoint Classification: Bio-equivalence Study
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.

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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Migraine
Headache

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Metoclopramide
Prochlorperazine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014