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
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: metoclopramide
Drug: Diphenhydramine 25mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metoclopramide for Acute Migraine: A Dose Finding Study

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 349
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
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: 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 40 mg
Drug: Diphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

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

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute migraine

Exclusion Criteria:

  • secondary cause of headache
  • lumbar puncture
  • allergy or intolerance to study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682734

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W. Friedman, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00682734     History of Changes
Other Study ID Numbers: MetoclopramideDFS
Study First Received: May 19, 2008
Results First Received: July 24, 2011
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diphenhydramine
Metoclopramide
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014