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Completed

NCT Number: NCT00682734

Metoclopramide for 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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute migraine

Exclusion criteria

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

Treatment and study plan

Metoclopramide

Drug

metoclopramide 20 mg

Diphenhydramine 25mg

Drug

Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Metoclopramide for Acute Migraine: A Dose Finding Study

Acronym: MDFS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 22, 2008
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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