Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

NCT02314351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2017-01-04

No results posted yet for this study

Summary

Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.

Conditions

  • Migraine Disorders

Interventions

DRUG

Metoclopramide 10 mg

Intravenous form of metoclopramide is in the same appearance with placebo

DRUG

Placebo

Intravenous form of metoclopramide is in the same appearance with placebo

DRUG

Fentanyl

Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Nurettin Özgür Doğan, Assoc. Prof · Kocaeli University, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314351 on ClinicalTrials.gov