MigraineNCT00363571
The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.
A study testing GTN, Diamox in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- GTN, Diamox
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to May 2007
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers; men and women age 18-50 years.
- weight 50-100 kg
Who cannot join
- Tension type headache more then once per month during the last year.
- Other primary headache types.
- Daily use of medication.
- Pregnant or lactating women.
- Headache on the trail day or 24 hours prior to the trial.
- Contraindications to MRI.
- Hypotension og hypertension.
- Other significant medical conditions judged by the doctor in charge.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Neurological Dep. Glostrup hospital
Glostrup Municipality, 2770
About this study
Official title: The Effect of Glyceryl Trinitrate (GTN) and Diamox on Cerebral Haemodynamics Judged With the Help of 3-Tesla MRI.
After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.
Read the detailed description
Experimental headache model open a unike opportunity to study the pathophysiological mechanisms behind headache in general and migrane in particular. Previous studies have used various techniques to study the cerebral haemodynamics as a basis for the headache pathophysiology. We wish to use a 3-Tesa MRI so study the cerebral haemodynamics after application of various pharmacological substances.
The most used experimental headache model is the glyceryl trinitrate model (GTN). Where infusion of the NO donor GTN induces headache and changes in the cerebral arteries. On the other hand injection of Diamox (Acetazolamide) apparently causes increase of the cerebral blod flow with out dilation of the arteries. We wish to study the precise effect of GTN and diamox on the cerebral haemodynamics such as Cerebral blod flow (CBF) and Cerebral blod volume (CBV) via a 3-Tesla MRI.
- Conditions
- Migraine
- Being tested
- GTN, Diamox
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTN, DiamoxDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Messoud Ashina, MD,Ph.D, Study chair, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363571
- Sponsor's protocol ID
- KA-20060084
- Status last verified
- Jul 2006
- First submitted
- 14 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glyceryl Trinitrate (GTN) and Diamox on Cerebral Haemodynamics Judged With the Help of 3-Tesla MRI.
- ClinicalTrials.gov ID
- NCT00363571
- Acronym / sponsor ID
- KA-20060084
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- May 2007
- First posted
- 15 Aug 2006 (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.
After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.
Detailed description
Experimental headache model open a unike opportunity to study the pathophysiological mechanisms behind headache in general and migrane in particular. Previous studies have used various techniques to study the cerebral haemodynamics as a basis for the headache pathophysiology. We wish to use a 3-Tesa MRI so study the cerebral haemodynamics after application of various pharmacological substances.
The most used experimental headache model is the glyceryl trinitrate model (GTN). Where infusion of the NO donor GTN induces headache and changes in the cerebral arteries. On the other hand injection of Diamox (Acetazolamide) apparently causes increase of the cerebral blod flow with out dilation of the arteries. We wish to study the precise effect of GTN and diamox on the cerebral haemodynamics such as Cerebral blod flow (CBF) and Cerebral blod volume (CBV) via a 3-Tesla MRI.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteers; men and women age 18-50 years.
- weight 50-100 kg
Key exclusion criteria (8 listed)
- Tension type headache more then once per month during the last year.
- Other primary headache types.
- Daily use of medication.
- Pregnant or lactating women.
- Headache on the trail day or 24 hours prior to the trial.
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 |
|---|---|---|
| GTN, Diamox | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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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.
Messoud Ashina, MD,Ph.D study chair
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTN, Diamox in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
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 2 inclusion and 8 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 15 Aug 2006. 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 Denmark. 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.
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?
Contact Mohammad Sohail Asghar, MD (+4543232161, asgsoh01@glostruphosp.kbhamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Aug 2006.