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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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. - Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.
Timepoint [1] 0 0
48 hours
Primary outcome [2] 0 0
Proportion of Patients With Recurrent Headache Within 48 Hours. - Proportion of patients who report recurrent headache within 48 hours, on telephone followup.
Timepoint [2] 0 0
48 hours
Secondary outcome [1] 0 0
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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00216736
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

Summary results
Other publications