NCT00733382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

Enrollment Period

10 months

First QC Date

August 11, 2008

Last Update Submit

August 11, 2008

Conditions

Keywords

migrainedexamethasonedihydroergotamine

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

1

EXPERIMENTAL
Drug: dexamethazone

2

ACTIVE COMPARATOR
Drug: dexamethazone

Interventions

injection form, 8 miligram, injected once

12

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peyman Petramfar

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

August 1, 2009

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations