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

NCT02794441 | Completed Phase 3 Results DMC

• 1 other identifier: 20150453
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Outcome Measures

Primary Outcomes (1)

• Headache Recurrence at 48 Hours

  The primary outcome will be headache recurrence 48 hours after discharge from the ED. Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie. pain intensity of 0), any return of head pain (ie. pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie. an increase in their score on the 4-point scale as compared to their score at ED discharge).

  48 hours

Secondary Outcomes (8)

• Pain Intensity

  Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)

• Persistent Pain Freedom

  2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours

• Patient Satisfaction

  At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-up

• Headache Recurrence at 7 Day Follow-up

  7 days

• Revisits Within 7 Days of Discharge From the ED

  7 days

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Matched oral solution in same volume per kg as dexamethasone

Other: Placebo

Interventions

Dexamethasone DRUG

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

Dexamethasone

Placebo OTHER

Matched oral solution

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 8 and 18 years (ie. \> 8.0 years and \< 18.0 years)
• Diagnosed with migraine according to a modified version of International Classification of Headache Disorders 3rd edition (ICHD-3, beta version) where criterion A (ie. minimum of 5 prior episodes meeting criteria B-D) has been removed to increase sensitivity of diagnosis in the emergency department setting

You may not qualify if:

• Received a dose of a steroid medication in the past 7 days
• Known allergy to dexamethasone
• Immunosuppressed
• Cushing's syndrome
• Known diabetes mellitus
• Known peptic or duodenal ulcer or other major gastrointestinal illness (ex. ulcerative colitis)
• Known myasthenia gravis
• Glaucoma
• Febrile at triage
• History of head trauma in the past 7 days
• Presence of any known active infection (eg. on antibiotics or antivirals, diagnosed with active infection in the ED, etc)
• Current secondary headache (as per the treating physician's clinical impression)

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (2)

• Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.

  PMID: 22384463 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

  PMID: 23771276 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

This study was designed as a pilot trial to assess trial protocol feasibility. Statistical hypothesis testing was not conducted on any of the outcome variables because of the small sample size and the inability to draw inferences from this data.

Results Point of Contact

• Title: Dr. Roger Zemek
• Organization: Children's Hospital of Eastern Ontario Research Institute

rzemek@cheo.on.ca

6137377600

Study Officials

• Roger Zemek, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, CHEO Research Institute; Director, CHEO Research Institute Clinical Research Unit; Emergency Physician, CHEO

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 9, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 28, 2017
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)