NCT00363792

Brief Summary

In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are:

  • Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
  • Changes in the diameter of a. cerebri media.
  • Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 15, 2006

Status Verified

August 1, 2006

First QC Date

August 11, 2006

Last Update Submit

August 11, 2006

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (3)

  • Changes in BOLD response

  • Changes in a. cerebri media diameter

  • Changes in CBF

Secondary Outcomes (1)

  • headache score

Interventions

Glyceryl trinitrate, azetazolamideDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • age 18-55 years
  • weight 50-100 kg

You may not qualify if:

  • Tension type headache more the once per month.
  • other types of headache
  • Daily use of medication other the birthcontrol pills.
  • Pregnant or lactating women.
  • headache on the examination date.
  • contraindications to MRI-scan.
  • hypotension or hypertension.
  • mental illness og substance abuse.
  • other significant conditions determined by the examining doctor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2770, Denmark

RECRUITING

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Messoud Ashina, MD, Phd,

    Danish Headache Center

    STUDY CHAIR

Central Study Contacts

Mohammad Sohail Asghar, MD

CONTACT

+4543232161asgsoh01@glostruphosp.kbhamt.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Completion

May 1, 2007

Last Updated

August 15, 2006

Record last verified: 2006-08

Locations

DK(1)