Text Size

Effect of Dexamethasone on Migraine Headache

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Shiraz University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00733382
First received: August 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
Migraine Headache
 Drug: dexamethazone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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.

Resource links provided by NLM:

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

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: dexamethazone
injection form, 8 miligram, injected once
Active Comparator: 2 Drug: dexamethazone
injection form, 8 miligram, injected once

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733382

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

No publications provided

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
Study First Received: August 11, 2008
Last Updated: August 11, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
migraine
dexamethasone
dihydroergotamine

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

ClinicalTrials.gov processed this record on May 16, 2013