We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effect of Dexamethasone on Migraine Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00733382
Recruitment Status : Unknown
Verified August 2008 by Shiraz University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2008
Last Update Posted : August 13, 2008
Information provided by:
Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: dexamethazone Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733382

Iran, Islamic Republic of
Peyman Petramfar
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences

Responsible Party: Reza Nemati/research manager of neurology department, Shiraz university of medical sciences
ClinicalTrials.gov Identifier: NCT00733382     History of Changes
Other Study ID Numbers: 212110
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by Shiraz University of Medical Sciences:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action