Metoclopramide for Migraine: A Dose Finding Study (MDFS)

May 1, 2018 updated by: Benjamin W. Friedman, MD, Montefiore Medical Center

Metoclopramide for Acute Migraine: A Dose Finding Study

Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute migraine

Exclusion Criteria:

  • secondary cause of headache
  • lumbar puncture
  • allergy or intolerance to study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
Drug: metoclopramide
metoclopramide 20 mg
Drug: metoclopramide
metoclopramide 40 mg
Drug: metoclopramide
metoclopramide 10 mg
Drug: Diphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Experimental: 2
metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
Drug: metoclopramide
metoclopramide 20 mg
Drug: metoclopramide
metoclopramide 40 mg
Drug: metoclopramide
metoclopramide 10 mg
Drug: Diphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Experimental: 3
metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
Drug: metoclopramide
metoclopramide 20 mg
Drug: metoclopramide
metoclopramide 40 mg
Drug: metoclopramide
metoclopramide 10 mg
Drug: Diphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score
Time Frame: Baseline, 60 minutes
Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
Baseline, 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W. Friedman, MD, MS, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-11-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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