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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01750723
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Headache Migraine Drug: Acetazolamide Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Basic Research on Acetazolamide´s Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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 Name: Diamox

Placebo Comparator: Saline
Saline, 10 ml i.v. infusion

Primary Outcome Measures :
  1. Headache scores [ Time Frame: 24 h ]
    Comparison between Acetazolamide and placebo (saline).

Secondary Outcome Measures :
  1. Artery circumference [ Time Frame: Baseline, 30 min and 60 min ]
    Acetazolamide induced changes in intracranial artery circumference before and after infusions.

  2. Cerebral blood flow [ Time Frame: Baseline, 30 and 60 min. ]
    Acetazolamide induced changes in cerebral blood flow.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01750723

Danish Headache Center
Copenhagen, Glostrup, Denmark, 2600
Department of Neurology
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Principal Investigator: Nanna Arngrim, MD Danish Headache Center

Responsible Party: Nanna Arngrim, MD, medical doctor, Danish Headache Center Identifier: NCT01750723     History of Changes
Other Study ID Numbers: H-3-2012-137
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by Nanna Arngrim, Danish Headache Center:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs