Metoclopramide for Migraine: A Dose Finding Study - Full Text View

Sponsor:	Montefiore Medical Center
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00682734

Purpose

Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the bets dose to administer. This study compares three different doses of metoclorpamide.

Condition	Intervention	Phase
Migraine	Drug: metoclopramide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Metoclopramide for Acute Migraine: A Dose Finding Study

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Metoclopramide hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Pain intensity score [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Headache-related disability [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator metoclorpamide 10mgIV + diphenhydramine 25mg IV	Drug: metoclopramide metoclopramide 10mg IV
2: Experimental metoclopramide 20mg IV + diphenhydrmaine 25mg IV	Drug: metoclopramide metoclopramide 20mg IV
3: Experimental metoclopramide 40mg IV + diphenhdyramine 25mg IV	Drug: metoclopramide metoclopramide 40mgIV

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

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

Locations

United States, New York
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin W Friedman, MD, MS 718-920-6626 befriedm@montefiore.org
Principal Investigator: Benjamin W Friedman, MD, MS

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator:

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

More Information

No publications provided

Responsible Party:	Albert Einstein College of Medicine ( Benjamin Friedman, MD )
Study ID Numbers:	MetoclopramideDFS
Study First Received:	May 19, 2008
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00682734 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Central Nervous System Diseases
Antiemetics
Dopamine Antagonists
Headache Disorders, Primary
Brain Diseases

Metoclopramide
Pharmacologic Actions
Headache Disorders
Migraine Disorders
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010