- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00682734
Metoclopramide for Migraine: A Dose Finding Study (MDFS)
May 1, 2018 updated by: Benjamin W. Friedman, MD, Montefiore Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
349
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- acute migraine
Exclusion Criteria:
- secondary cause of headache
- lumbar puncture
- allergy or intolerance to study medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Metoclopramide 10 mg+ diphenhydramine 25 mg.
This medication was administered as an intravenous drip over 20 minutes
|
metoclopramide 20 mg
metoclopramide 40 mg
metoclopramide 10 mg
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.
|
metoclopramide 20 mg
metoclopramide 40 mg
metoclopramide 10 mg
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.
|
metoclopramide 20 mg
metoclopramide 40 mg
metoclopramide 10 mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin W. Friedman, MD, MS, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
May 19, 2008
First Submitted That Met QC Criteria
May 21, 2008
First Posted (Estimate)
May 22, 2008
Study Record Updates
Last Update Posted (Actual)
May 31, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Dopamine Agents
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Diphenhydramine
- Promethazine
- Metoclopramide
Other Study ID Numbers
- 07-11-405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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