Metoclopramide for Migraine: A Dose Finding Study

NCT ID: NCT00682734

Last Updated: 2018-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

metoclopramide 10 mg

Diphenhydramine 25mg

Intervention Type DRUG

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

2

metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.

Group Type EXPERIMENTAL

metoclopramide

Intervention Type DRUG

metoclopramide 20 mg

Diphenhydramine 25mg

Intervention Type DRUG

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

3

metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.

Group Type EXPERIMENTAL

metoclopramide

Intervention Type DRUG

metoclopramide 40 mg

Diphenhydramine 25mg

Intervention Type DRUG

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

Interventions

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metoclopramide

metoclopramide 20 mg

Intervention Type DRUG

metoclopramide

metoclopramide 40 mg

Intervention Type DRUG

metoclopramide

metoclopramide 10 mg

Intervention Type DRUG

Diphenhydramine 25mg

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* acute migraine

Exclusion Criteria

* secondary cause of headache
* lumbar puncture
* allergy or intolerance to study medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Benjamin W. Friedman, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin W. Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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07-11-405

Identifier Type: -

Identifier Source: org_study_id

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