Metoclopramide for Migraine: A Dose Finding Study (MDFS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00682734
First received: May 19, 2008
Last updated: November 28, 2012
Last verified: November 2012

May 19, 2008
November 28, 2012
April 2008
March 2010   (final data collection date for primary outcome measure)
Pain Intensity Score [ Time Frame: Baseline, 60 minutes ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00682734 on ClinicalTrials.gov Archive Site
Not Provided
Headache-related disability [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682734
MetoclopramideDFS
Yes
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