A Clinical Trial Comparing Two Different Medications to Determine Which One is Better for Patients With an Acute Migraines in the Emergency Department
Information source: Montefiore Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Prochlorperazine (Drug); Metoclopramide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s):
Benjamin W Friedman, MD, MS, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Summary
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.
Clinical Details
Official title: Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Primary outcome: One hour pain scores
Secondary outcome: One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467, United States
Additional Information
Starting date: August 2006
Ending date: March 2007
Last updated: May 19, 2008
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