Metoclopramide for Migraine: A Dose Finding Study

Migraine Clinical Trial

— MDFS  

Official title:

Metoclopramide for Acute Migraine: A Dose Finding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682734
• Other study ID #: 07-11-405
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• acute migraine

Exclusion Criteria:

• secondary cause of headache

• lumbar puncture

• allergy or intolerance to study medication

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• metoclopramide
metoclopramide 20 mg
• metoclopramide
metoclopramide 40 mg
• metoclopramide
metoclopramide 10 mg
• Diphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Score	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