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| Sponsors and Collaborators: |
Montefiore Medical Center Albert Einstein College of Medicine of Yeshiva University |
|---|---|
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00364806 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Principal Investigator: | Benjamin W Friedman, MD, MS | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Responsible Party: | Montefiore Medical Center ( Benjamin friedman ) |
| Study ID Numbers: | Migraine 3 |
| Study First Received: | August 14, 2006 |
| Last Updated: | May 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00364806 |
| Health Authority: | United States: Institutional Review Board |
|
Migraine Headache |
|
Prochlorperazine Dopamine Migraine Disorders Headache Central Nervous System Diseases |
Emergencies Headache Disorders, Primary Brain Diseases Metoclopramide Headache Disorders |
|
Neurotransmitter Agents Disease Attributes Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
