Effect of Dexamethasone on Migraine Headache

August 11, 2008 updated by: Shiraz University of Medical Sciences

The Effect of Dexamethasone in the Attack of Migraine Headache and to Prevent of Its Relapse After Discharge From Emergency Department: a Randomized, Double-Blind, Controlled Trial.

Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is never evaluate and not correlate with the effect of popular anti migraine medication such as dihydroergotamine. The investigators proposal is to compare its effect with dihydroergotamine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Migraine attack according to international headache society criteria

  2. Migraine without aura; at least 5 attack with mean duration of 4 to 72 hours and 2 of following:

    • Unilateral
    • Pulsatile
    • Severe enough to impair daily activity

    • Aggravate with walking and climbing, also 1 of following:

      • Nausea and or vomiting
      • Photophobia and phonophobia, and not contributed to other headache.

  3. Migraine with aura; at least 2 attacks with 3 of following:

    • One reversible aura
    • Aura became apparent at least in 4 minutes
    • Aura not lasting more than 60 minutes
    • Headache develops in less than 60 minutes after aura

Exclusion Criteria:

  1. Hypertension
  2. Ischemic heart disease

  3. Basilar migraine with sign and symptoms such as:

    • Diplopia
    • Ataxia
    • Dysarthria
    • Dysphagia
    • Weakness
    • Sensory disorder
    • Drowsiness
  4. Peripheral vascular disease
  5. Sepsis
  6. Age more than 40 and less than 15 year old
  7. Pregnancy
  8. Use of triptans and ergots derivatives in past 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: dexamethazone
injection form, 8 miligram, injected once
Active Comparator: 2
Drug: dexamethazone
injection form, 8 miligram, injected once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2008

Last Update Submitted That Met QC Criteria

August 11, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Headache

Clinical Trials on dexamethazone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe