NCT02314351

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

December 5, 2014

Last Update Submit

January 3, 2017

Conditions

Migraine Disorders

Keywords

migraine disordersmigraine with auramigraine without aurapain managementemergency department

Outcome Measures

Primary Outcomes (1)

  • The difference between pain scores for both drugs

    The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups

    15th and 30th minutes

Secondary Outcomes (5)

  • Nausea and vomiting

    30th minute

  • Adverse reactions

    30th minute

  • Need for rescue analgesic

    30th minute

  • Change in the headache intensity

    Between 24th and 72th hours

  • Duplicative presentation to the emergency department

    Between 24th and 72th hours

Study Arms (2)

Intravenous metoclopramide

ACTIVE COMPARATOR

Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)

Drug: Metoclopramide 10 mgDrug: PlaceboDrug: Fentanyl

Placebo

PLACEBO COMPARATOR

0.9% normal saline solution (total 100 mL)

Drug: Metoclopramide 10 mgDrug: PlaceboDrug: Fentanyl

Interventions

Metoclopramide 10 mgDRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Also known as: Metoclopramide 10 mg (2 mL) in 100 mL normal saline
Intravenous metoclopramidePlacebo
PlaceboDRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Also known as: 100 mL normal saline
Intravenous metoclopramidePlacebo
FentanylDRUG

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

Also known as: Intravenous fentanyl
Intravenous metoclopramidePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
  • The patients older than 18 years
  • Patients who agree to participate to the study by reading and signing the informed consent document

You may not qualify if:

  • The patients younger than 18 years
  • Pregnants
  • Patients taking any analgesic drugs last 2 hours
  • Documented or declared allergy to metoclopramide
  • Patients who are hemodynamically unstable
  • Patients who do not agree to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Medicine

Köseköy, Kocaeli, 41000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without AuraAgnosiaEmergencies

Interventions

MetoclopramideSaline SolutionFentanyl

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nurettin Özgür Doğan, Assoc. Prof

    Kocaeli University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 11, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

TU(1)