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Oral Dexamethasone for Treatment of Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Dexamethasone
placebo
Sponsored by
The Joseph Epstein Centre for Emergency Medicine Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Migraine, Headache, Rebound headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up Exclusion Criteria: Failure to consent Pregnancy Allergy to study medication Findings inconsistent with migraine Patients requiring hospital admission for further investigation and treatment Patients with active peptic ulcer disease Patients with Type 1 diabetes Patients taking corticosteroids for another condition within 7 days Active systemic fungal infection Patients previously enrolled in the study

Sites / Locations

  • Department of Emergency Medicine, Western Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.

This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency department discharge. Patients and clinicians were blinded.

Outcomes

Primary Outcome Measures

Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Proportion of Patients With Recurrent Headache Within 48 Hours.
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.

Secondary Outcome Measures

Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.

Full Information

First Posted
September 14, 2005
Last Updated
April 13, 2015
Sponsor
The Joseph Epstein Centre for Emergency Medicine Research
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1. Study Identification

Unique Protocol Identification Number
NCT00216736
Brief Title
Oral Dexamethasone for Treatment of Migraine
Official Title
Does a Single Oral Dose of Dexamethasone After Successful Emergency Treatment of Migraine Reduce the Incidence or Severity of Rebound Headache Within 48 Hours?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Joseph Epstein Centre for Emergency Medicine Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) [after successful treatment] prevents rebound headache. Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED.
Detailed Description
Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments [ED], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to function normally [eg work, social, etc].It appears that inflammation plays a key role in recurrences. A number of small studies suggest that a single dose of corticosteroids at the time of discharge might prevent rebound headache. To date these studies have used intravenous dexamethasone. The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the ED [after successful treatment] prevents rebound headache. Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after treatment for migraine in the ED. Aims: The primary aim is to compare the proportion of patients who experience rebound headache within 48 hours after ED treatment of migraine between a group treated with single dose oral dexamethasone 8mg and a group treated with placebo. Secondary aims are to compare headache severity, analgesia/ health service use, adverse events and return to normal functioning between the groups. Methods: Study design: Double blind, randomised placebo controlled clinical trial. Setting: Emergency Department, Western Hospital. Participants: Adult patients [age >17 years] with physician-diagnosed migraine treated in the ED. Inclusion criteria: Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up. Sample size: 76 patients. Note: The study was stopped early for operational reasons. 63 patients were analysed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache, Rebound headache

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
Arm Title
2
Arm Type
Experimental
Arm Description
This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency department discharge. Patients and clinicians were blinded.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Single dose oral dexamethasone 8mg at time of ED discharge
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose oral placebo at ED discharge
Primary Outcome Measure Information:
Title
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
Description
Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Time Frame
48 hours
Title
Proportion of Patients With Recurrent Headache Within 48 Hours.
Description
Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
Description
Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consenting adult patients [age >17 years] with physician-diagnosed migraine treated in the ED who are willing and able to be contacted between 48-72 hours after discharge for follow-up Exclusion Criteria: Failure to consent Pregnancy Allergy to study medication Findings inconsistent with migraine Patients requiring hospital admission for further investigation and treatment Patients with active peptic ulcer disease Patients with Type 1 diabetes Patients taking corticosteroids for another condition within 7 days Active systemic fungal infection Patients previously enrolled in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Maree Kelly, MB BS
Organizational Affiliation
The Joseph Epstein Centre for Emergency Medicine Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Emergency Medicine, Western Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
18156535
Citation
Kelly AM, Kerr D, Clooney M. Impact of oral dexamethasone versus placebo after ED treatment of migraine with phenothiazines on the rate of recurrent headache: a randomised controlled trial. Emerg Med J. 2008 Jan;25(1):26-9. doi: 10.1136/emj.2007.052068.
Results Reference
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Oral Dexamethasone for Treatment of Migraine

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