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Effect of Dexamethasone on Migraine Headache

Primary Purpose

Migraine Headache

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
dexamethazone
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring migraine, dexamethasone, dihydroergotamine

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peyman Petramfar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 11, 2008
Last Updated
August 11, 2008
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00733382
Brief Title
Effect of Dexamethasone on Migraine Headache
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
migraine, dexamethasone, dihydroergotamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dexamethazone
Intervention Description
injection form, 8 miligram, injected once
Primary Outcome Measure Information:
Title
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Migraine attack according to international headache society criteria 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. 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: Hypertension Ischemic heart disease Basilar migraine with sign and symptoms such as: Diplopia Ataxia Dysarthria Dysphagia Weakness Sensory disorder Drowsiness Peripheral vascular disease Sepsis Age more than 40 and less than 15 year old Pregnancy Use of triptans and ergots derivatives in past 24 hours
Facility Information:
Facility Name
Peyman Petramfar
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Dexamethasone on Migraine Headache

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