The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.

August 14, 2006 updated by: Danish Headache Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2770
        • Danish Headache Center, Neurological Dep. Glostrup hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Study Chair: Messoud Ashina, MD,PH.d, Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion

December 6, 2022

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 14, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-20060084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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