Metoclopramide for Migraine: A Dose Finding Study

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: metoclopramide; Drug: Diphenhydramine 25mg

• Registration Number: NCT00682734
• Lead Sponsor: Montefiore Medical Center

Brief 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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-07-24
• Results First Submitted QC: 2012-11-28
• Results First Posted: 2012-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• acute migraine

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	metoclopramide	metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
1	Diphenhydramine 25mg	Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
3	Diphenhydramine 25mg	metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
2	Diphenhydramine 25mg	metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
2	metoclopramide	metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
1	metoclopramide	Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes

Primary Outcome Measures

Name	Time	Method
Pain Intensity Score	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States