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...
Date First Received: May 19, 2008
Last Updated: February 14, 2009
Verified by: Montefiore Medical Center, February 2009
Clinical Trial Phase: Phase 3 | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 330
Brief Summary
Official Title: “Metoclopramide for Acute Migraine: A Dose Finding Study”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: May 2010
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: metoclopramide
- metoclopramide 20mg IV
- Drug: metoclopramide
- metoclopramide 40mgIV
- Drug: metoclopramide
- metoclopramide 10mg IV
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- metoclorpamide 10mgIV + diphenhydramine 25mg IV
- Experimental: 2
- metoclopramide 20mg IV + diphenhydrmaine 25mg IV
- Experimental: 3
- metoclopramide 40mg IV + diphenhdyramine 25mg IV
Outcome Measures for this Clinical Trial
Primary Measures
- Pain intensity score
- Time Frame: 60 minutes
Safety Issue?: No
- Time Frame: 60 minutes
Secondary Measures
- Headache-related disability
- Time Frame: 60 minutes
Safety Issue?: No
- Time Frame: 60 minutes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- acute migraine
Exclusion Criteria:
- secondary cause of headache
- lumbar puncture
- allergy or intolerance to study medication
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 69 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Montefiore Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682734
Study ID Number: MetoclopramideDFS
ClinicalTrials.gov Identifier: NCT00682734
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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