Migraine HeadachePhase 1NCT00733382
Effect of Dexamethasone on Migraine Headache
A Phase 1 study testing dexamethazone in people with Migraine Headache, run by Shiraz University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- dexamethazone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- Hypertension
- Ischemic heart disease
- Basilar migraine with sign and symptoms such as:
- Diplopia
- Ataxia
- Dysarthria
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Migraine Headache
- Being tested
- dexamethazone
- Keywords
- migraine, dexamethasone, dihydroergotamine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethazoneDrug
injection form, 8 miligram, injected once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: dexamethazone |
| 2 | Active comparator | Not described Receives: Drug: dexamethazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733382
- Sponsor's protocol ID
- 212110
- Status last verified
- Aug 2008
- First submitted
- 11 Aug 2008
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00733382
- Acronym / sponsor ID
- 212110
- Conditions
- Migraine Headache
- Keywords
- migraine, dexamethasone, dihydroergotamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dexamethazone |
| 2 | Active comparator | Drug: dexamethazone |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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:
- Migraine with aura; at least 2 attacks with 3 of following:
Key exclusion criteria (15 listed)
- Hypertension
- Ischemic heart disease
- Basilar migraine with sign and symptoms such as:
- Peripheral vascular disease
- Sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethazoneinjection form, 8 miligram, injected once | Drug | 1, 2 |
Primary outcome
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dexamethazone in people with Migraine Headache, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2008.