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Metoclopramide for Migraine: A Dose Finding Study (MDFS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00682734
First Posted: May 22, 2008
Last Update Posted: December 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
May 19, 2008
May 22, 2008
July 24, 2011
December 31, 2012
December 31, 2012
April 2008
March 2010   (Final data collection date for primary outcome measure)
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.
Pain Intensity Score [ Time Frame: 60 minutes ]
Complete list of historical versions of study NCT00682734 on ClinicalTrials.gov Archive Site
Not Provided
Headache-related disability [ Time Frame: 60 minutes ]
Not Provided
Not Provided
 
Metoclopramide for Migraine: A Dose Finding Study
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.
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine
  • 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
  • Active Comparator: 1
    Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
    Interventions:
    • Drug: metoclopramide
    • Drug: Diphenhydramine 25mg
  • Experimental: 2
    metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
    Interventions:
    • Drug: metoclopramide
    • Drug: Diphenhydramine 25mg
  • Experimental: 3
    metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
    Interventions:
    • Drug: metoclopramide
    • Drug: Diphenhydramine 25mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
349
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute migraine

Exclusion Criteria:

  • secondary cause of headache
  • lumbar puncture
  • allergy or intolerance to study medication
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00682734
MetoclopramideDFS
Yes
Not Provided
Not Provided
Benjamin Friedman, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Benjamin W. Friedman, MD, MS Montefiore Medical Center
Montefiore Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP