The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.

NCT ID: NCT00363571

Last Updated: 2006-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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GTN, Diamox

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers; men and women age 18-50 years.
* weight 50-100 kg

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Principal Investigators

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Messoud Ashina, MD,Ph.D

Role: STUDY_CHAIR

Danish Headache Center

Locations

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Danish Headache Center, Neurological Dep. Glostrup hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Mohammad Sohail Asghar, MD

Role: CONTACT

Phone: +4543232161

Email: [email protected]

Other Identifiers

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KA-20060084

Identifier Type: -

Identifier Source: org_study_id