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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.
Study NCT00364806   Information provided by Montefiore Medical Center
First Received: August 14, 2006   Last Updated: May 19, 2008   History of Changes

August 14, 2006
May 19, 2008
August 2006
March 2007   (final data collection date for primary outcome measure)
One hour pain scores
Same as current
Complete list of historical versions of study NCT00364806 on ClinicalTrials.gov Archive Site
One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
Same as current
 
A Clinical Trial Comparing Two Different Medications to Determine Which One is Better for Patients With an Acute Migraines in the Emergency Department
Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Migraine
  • Drug: Prochlorperazine
  • Drug: Metoclopramide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
76
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00364806
Benjamin friedman, Montefiore Medical Center
Migraine 3
Montefiore Medical Center
Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP