Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study

Study Primary Completion Date: March 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Prochlorperazine
• Drug: Metoclopramide

Primary Measures

• One hour pain scores

Secondary Measures

• One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Montefiore Medical Center

Overall Clinical Trial Officials and Contacts

Benjamin W Friedman, MD, MS Principal Investigator Albert Einstein College of Medicine of Yeshiva University  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00364806

Study ID Number: Migraine 3

ClinicalTrials.gov Identifier: NCT00364806

Health Authority: United States: Institutional Review Board