Prochlorperazine vs Metoclopramide
Primary Purpose
Migraine
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prochlorperazine
Metoclopramide
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache
Eligibility 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
Sites / Locations
- Montefiore Medical Center
Outcomes
Primary Outcome Measures
One hour pain scores
Secondary Outcome Measures
One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
Full Information
NCT ID
NCT00364806
First Posted
August 14, 2006
Last Updated
April 15, 2018
Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00364806
Brief Title
Prochlorperazine vs Metoclopramide
Official Title
Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
76 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Primary Outcome Measure Information:
Title
One hour pain scores
Secondary Outcome Measure Information:
Title
One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
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Prochlorperazine vs Metoclopramide
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