The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.

Migraine Clinical Trial

Official title:

The Effect of Glyceryl Trinitrate (GTN) and Diamox on Cerebral Haemodynamics Judged With the Help of 3-Tesla MRI.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00363571
• Other study ID #: KA-20060084
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2006
• Last updated: August 14, 2006
• Start date: August 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2006
• Source: Danish Headache Center
• Contact: Mohammad Sohail Asghar, MD
• Phone: +4543232161
• Email: asgsoh01[@]glostruphosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• GTN, Diamox

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Neurological Dep. Glostrup hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark,