Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00216736




Registration number
NCT00216736
Ethics application status
Date submitted
14/09/2005
Date registered
22/09/2005
Date last updated
30/04/2015

Titles & IDs
Public title
Oral Dexamethasone for Treatment of Migraine
Scientific 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?
Secondary ID [1] 0 0
2004.221
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexamethasone
Treatment: Drugs - placebo

Placebo comparator: 1 - This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.

Experimental: 2 - 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.


Treatment: Drugs: Dexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge

Treatment: Drugs: placebo
Single dose oral placebo at ED discharge
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.
Timepoint [1] 0 0
48 hours
Primary outcome [2] 0 0
Proportion of Patients With Recurrent Headache Within 48 Hours.
Timepoint [2] 0 0
48 hours
Secondary outcome [1] 0 0
Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.
Timepoint [1] 0 0
48 hours

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Emergency Medicine, Western Health - Melbourne
Recruitment postcode(s) [1] 0 0
3011 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Joseph Epstein Centre for Emergency Medicine Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Anne-Maree Kelly, MB BS
Address 0 0
The Joseph Epstein Centre for Emergency Medicine Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Kelly AM, Kerr D, Clooney M. Impact of oral dexame... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00216736