Oral Dexamethasone for Treatment of Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Anne-Maree Kelly, The Joseph Epstein Centre for Emergency Medicine Research
ClinicalTrials.gov Identifier:
NCT00216736
First received: September 14, 2005
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Dexamethasone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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?

Resource links provided by NLM:


Further study details as provided by The Joseph Epstein Centre for Emergency Medicine Research:

Primary Outcome Measures:
  • Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.


Enrollment: 63
Study Start Date: April 2005
Study Completion Date: July 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded.
Drug: placebo
Single dose oral placebo at ED discharge
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.
Drug: Dexamethasone
Single dose oral dexamethasone 8mg at time of ED discharge

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216736

Locations
Australia, Victoria
Department of Emergency Medicine, Western Health
Melbourne, Victoria, Australia, 3011
Sponsors and Collaborators
The Joseph Epstein Centre for Emergency Medicine Research
Investigators
Principal Investigator: Anne-Maree Kelly, MB BS The Joseph Epstein Centre for Emergency Medicine Research
  More Information

Publications:
Responsible Party: Professor Anne-Maree Kelly, Director JECEMR, The Joseph Epstein Centre for Emergency Medicine Research
ClinicalTrials.gov Identifier: NCT00216736     History of Changes
Other Study ID Numbers: 2004.221
Study First Received: September 14, 2005
Results First Received: May 28, 2009
Last Updated: April 13, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Joseph Epstein Centre for Emergency Medicine Research:
Migraine
Headache
Rebound headache

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 02, 2015