← Back to Search

Corticosteroid

IV Dexamethasone for Migraine

Phase 1
Recruiting
Led By Benoit Bailey, MD
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting a diagnosis of acute migraine
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 and 48h post intervention
Awards & highlights

Study Summary

This trial looks at the effectiveness of parenteral dexamethasone (a steroid) at preventing migraine recurrence in children.

Who is the study for?
This trial is for children aged 8-17 with severe migraines, treated in the ED with IV therapy. They must not have allergies to study drugs, be on corticosteroids, or have conditions like infections, heart failure, diabetes that contraindicate steroids.Check my eligibility
What is being tested?
The trial tests if IV dexamethasone can prevent migraine relapse in kids after ED discharge compared to a placebo. It's randomized and double-blind; patients also take naproxen and keep a headache diary post-treatment.See study design
What are the potential side effects?
Possible side effects of dexamethasone include increased risk of infection, blood sugar changes (important for diabetics), stomach irritation, mood swings or behavior changes especially in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with acute migraine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 and 48h post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 and 48h post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
incidence of relapse following discharge from the ED
Secondary outcome measures
adverse events after parenteral corticosteroids
associated symptoms (i.e. nausea, vomiting, photophobia and sonophobia)
mean level of pain
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Dexamethasone groupActive Control1 Intervention
Dexamethasone 0.6 mg/kg IV (max 15 mg) before departure from the ED.
Group II: Placebo groupPlacebo Group1 Intervention
The control group received a similar looking placebo (NaCl 0,9% IV) with the same volume.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
195 Previous Clinical Trials
79,176 Total Patients Enrolled
Benoit Bailey, MDPrincipal InvestigatorSte-Justine's Hospital

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02903680 — Phase 1
Migraine Research Study Groups: Dexamethasone group, Placebo group
Migraine Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02903680 — Phase 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02903680 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enrolling participants who are 55 years of age or older?

"Eligible participants are those aged between 8 and 18 years old."

Answered by AI

What is the current participant count for this research endeavor?

"Correct. According to clinicaltrials.gov, this research endeavour -- initially posted on May 1st 2014 -- is actively recruiting participants. Specifically, 116 people are needed from a single location."

Answered by AI

Has the Dexamethasone group been given the green light by the FDA?

"Our organisation's assessment of the Dexamethasone group yielded a score of 1 due to this being an early stage trial with scant data supporting its safety and efficacy."

Answered by AI

Am I eligible to participate in this experiment?

"This medical trial is interested in enrolling 116 participants with migraine aged between 8 and 18. Qualifying patients have the opportunity to take part."

Answered by AI

What conditions is the Dexamethasone cohort usually used to treat?

"Dexamethasone is frequently utilized to treat ophthalmia and sympathetic conditions. Additionally, this medication can be beneficial for patients managing eye issues such as branch retinal vein occlusion or macular edema."

Answered by AI

Has any additional research been done concerning the effects of Dexamethasone?

"At present, 552 clinical trials are being conducted on the Dexamethasone group. Of those active studies, 144 have advanced to Phase 3. Although most of them originate in Joliet, Illinois, there's a total of 18606 locations running research for this medication."

Answered by AI

Are there any vacancies left in this medical experiment?

"As per the information accessible on clinicaltrials.gov, this investigation is searching for suitable candidates; it was first shared on May 1st 2014 and has been revised on May 3rd 2022."

Answered by AI
~2 spots leftby Jun 2024