Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000034639
Ethics application status
Approved
Date submitted
20/07/2005
Date registered
22/07/2005
Date last updated
10/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a single oral dose of dexamethasone after successful emergency department treatment of migraine reduce the incidence or severity of rebound headache within 48 hours?
Scientific title
Does a single oral dose of dexamethasone after successful emergency department treatment of migraine reduce the incidence or severity of rebound headache within 48 hours?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 97 0
Condition category
Condition code
Neurological 118 118 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 41 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 148 0
Proportion of patients who were discharged pain free that have a recurrence of headache within 48 hours
Timepoint [1] 148 0
48 hours
Primary outcome [2] 149 0
Proportion of patients who were not pain free at discharge whose headache is worse or unchanged within 48 hours
Timepoint [2] 149 0
48 hours
Secondary outcome [1] 328 0
Comparison of headache severity.
Timepoint [1] 328 0
At Hospital Discharge
Secondary outcome [2] 329 0
Analgesia/ health service use
Timepoint [2] 329 0
48 hours
Secondary outcome [3] 330 0
Adverse events and return to normal functioning between the groups.
Timepoint [3] 330 0
48 hours

Eligibility
Key inclusion criteria
Consenting adult patients 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.
Minimum age
17 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered Containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation (in blocks)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 163 0
Charities/Societies/Foundations
Name [1] 163 0
Eirene Lucas Foundation
Country [1] 163 0
Australia
Primary sponsor type
Hospital
Name
The Joseph Epstein Centre for Emergency Medicine Research
Address
The Joseph Epstein Centre for Emergency Medicine Research (JECEMR)
Sunshine Hospital
176 Furlong Rd
St Albans Victoria 3021
Country
Australia
Secondary sponsor category [1] 118 0
None
Name [1] 118 0
Nil
Address [1] 118 0
Country [1] 118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 908 0
The Melbourne Health Research Directorate
Ethics committee address [1] 908 0
Ethics committee country [1] 908 0
Australia
Date submitted for ethics approval [1] 908 0
Approval date [1] 908 0
Ethics approval number [1] 908 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35816 0
Address 35816 0
Country 35816 0
Phone 35816 0
Fax 35816 0
Email 35816 0
Contact person for public queries
Name 9230 0
Professor Anne-Maree Kelly
Address 9230 0
The Joseph Epstein Centre for Emergency Medicine Research
Department of Emergency Medicine
Western Hospital
Gordon St
Footscray VIC 3011
Country 9230 0
Australia
Phone 9230 0
+61 3 83456315
Fax 9230 0
+61 3 93184790
Email 9230 0
[email protected]
Contact person for scientific queries
Name 158 0
Debra Kerr
Address 158 0
The Joseph Epstein Centre for Emergency Medicine Research
Department of Emergency Medicine
Western Hospital
Gordon St
Footscray VIC 3011
Country 158 0
Australia
Phone 158 0
+61 3 83456454
Fax 158 0
+61 3 93184790
Email 158 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.