CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone 0.6mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02794441
NCT02794441Phase 3Completed

Oral Dexamethasone for the Treatment of Acute Migraine Recurrence in Pediatric Patients Presenting to the Emergency Department With Migraine: A Pilot Randomized Controlled Trial

Children's Hospital of Eastern Ontario·interventional·Posted Jun 9, 2016·Updated Dec 3, 2019

In Brief

A Phase 3 clinical trial evaluating Dexamethasone and Placebo for Migraine. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesCanada

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2016
Enrollment StartDec 1, 2016
Primary CompletionJun 1, 2017
Study CompletionJun 28, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.1 years ago

Interventions

Dexamethasonedrug

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

Placeboother

Matched oral solution