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Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in the Pediatric Emergency Department

NCT02794441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-12-03

Study results available
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Summary

Migraine recurrence is common amongst pediatric patients being discharged from the emergency department after treatment for migraine. Despite the commonality of migraine recurrence within the week following discharge, no known effective therapies are available in the pediatric population, though dexamethasone has been established as efficacious in the adult migraine population. The proposed study will randomly assign children and adolescents visiting the emergency department (ED) for migraine to receive either one dose of oral dexamethasone or oral placebo. Twenty patients will be recruited to this randomized, double-blind, pilot trial over a 6 month period, and the aim of the study will be to determine the feasibility and acceptability of the protocol.

Conditions

Interventions

DRUG

Dexamethasone

Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose

OTHER

Placebo

Matched oral solution

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Roger Zemek, MD · Children's Hospital of Eastern Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-06-30
Completion
2017-06-28

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

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 NCT02794441 on ClinicalTrials.gov