A Clinical Trial Comparing Two Different Medications to Determine Which One is Better for Patients With an Acute Migraines in the Emergency Department
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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 |
- One hour pain scores
- 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) |
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:
- 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| 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
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:
|
Emergencies Migraine Disorders Disease Attributes Pathologic Processes Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Metoclopramide Prochlorperazine Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013