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Metoclopramide for Migraine: A Dose Finding Study (MDFS)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
metoclopramide
metoclopramide
metoclopramide
Diphenhydramine 25mg
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute migraine

Exclusion Criteria:

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes

metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.

metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.

Outcomes

Primary Outcome Measures

Pain Intensity Score
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2008
Last Updated
May 1, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00682734
Brief Title
Metoclopramide for Migraine: A Dose Finding Study
Acronym
MDFS
Official Title
Metoclopramide for Acute Migraine: A Dose Finding Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
Arm Title
2
Arm Type
Experimental
Arm Description
metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
Arm Title
3
Arm Type
Experimental
Arm Description
metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
metoclopramide 20 mg
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
metoclopramide 40 mg
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
metoclopramide 10 mg
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine 25mg
Intervention Description
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Primary Outcome Measure Information:
Title
Pain Intensity Score
Description
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.
Time Frame
Baseline, 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute migraine Exclusion Criteria: secondary cause of headache lumbar puncture allergy or intolerance to study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W. Friedman, MD, MS
Organizational Affiliation
Montefiore Medical Center
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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Metoclopramide for Migraine: A Dose Finding Study

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