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Metoclopramide for Migraine: A Dose Finding Study (MDFS)

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ClinicalTrials.gov Identifier: NCT00682734
Recruitment Status : Completed
First Posted : May 22, 2008
Results First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: metoclopramide Drug: Diphenhydramine 25mg Phase 3

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  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metoclopramide for Acute Migraine: A Dose Finding Study
Study Start Date : April 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute migraine

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00682734     History of Changes
Other Study ID Numbers: MetoclopramideDFS
First Posted: May 22, 2008    Key Record Dates
Results First Posted: December 31, 2012
Last Update Posted: December 31, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diphenhydramine
Metoclopramide
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents