Overview

This trial is active, not recruiting.

Condition migraine headache
Treatment dexamethazone
Phase phase 1
Sponsor Shiraz University of Medical Sciences
Start date February 2008
End date December 2008
Trial size 30 participants
Trial identifier NCT00733382, 212110

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
dexamethazone
injection form, 8 miligram, injected once
(Active Comparator)
dexamethazone
injection form, 8 miligram, injected once

Primary Outcomes

Measure
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence
time frame:

Eligibility Criteria

Male or female participants from 15 years up to 40 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by Shiraz University of Medical Sciences.