Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow

July 8, 2013 updated by: Nanna Arngrim, Danish Headache Center

Basic Research on Acetazolamide´s Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model

In this study the investigators will research the hypothesis that the drug Acetazolamide induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the areas of the brain supplied by these arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To investigate headache score and accompanying symptoms during and after infusion of acetazolamide.

With magnetic resonance imaging the investigators will investigate changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), diameter of MCA, the Internal carotic artery (ICA), the superficial temporal artery (STA) and the Medial Meningeal artery (MMA).

Study Type

Interventional

Enrollment (Actual)

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
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center
      • Copenhagen, Glostrup, Denmark, 2600
        • Department of Neurology

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Aged 18-40
  • 50-100 kg
  • Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.

Exclusion Criteria:

  • Tension type headache more than once/month
  • Other primary headaches
  • Daily medication except contraceptives
  • Drug taken within 4 times the halflife for the specific drug except contraceptives
  • Pregnant or lactating women
  • Exposure to radiation within the last year
  • Headache within the last 24 hours before start of trial
  • Hypertension
  • Hypotension
  • Respiratory or cardiac disease

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetazolamide
Acetazolamide 1 g in 10 ml saline, i.v. infusion
Drug: Acetazolamide
1 g diluted in 10 ml saline, i.v. bolus injection.
Other Names:
  • Diamox
Placebo Comparator: Saline
Saline, 10 ml i.v. infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache scores
Time Frame: 24 h
Comparison between Acetazolamide and placebo (saline).
24 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artery circumference
Time Frame: Baseline, 30 min and 60 min
Acetazolamide induced changes in intracranial artery circumference before and after infusions.
Baseline, 30 min and 60 min
Cerebral blood flow
Time Frame: Baseline, 30 and 60 min.
Acetazolamide induced changes in cerebral blood flow.
Baseline, 30 and 60 min.

Collaborators and Investigators

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

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Nanna Arngrim, MD, 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

December 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2012-137

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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