Effect of Dexamethasone on Migraine Headache

Migraine Headache Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00733382
• Other study ID #: 212110
• Status: Active, not recruiting
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: August 11, 2008
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2008
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• dexamethazone
injection form, 8 miligram, injected once

Locations

Country	Name	City	State
Iran, Islamic Republic of	Peyman Petramfar	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence			Yes