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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01750723
First received: December 11, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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 Intervention
Headache
Migraine
Drug: Acetazolamide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Headache scores [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    Comparison between Acetazolamide and placebo (saline).


Secondary Outcome Measures:
  • Artery circumference [ Time Frame: Baseline, 30 min and 60 min ] [ Designated as safety issue: No ]
    Acetazolamide induced changes in intracranial artery circumference before and after infusions.

  • Cerebral blood flow [ Time Frame: Baseline, 30 and 60 min. ] [ Designated as safety issue: No ]
    Acetazolamide induced changes in cerebral blood flow.


Enrollment: 12
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750723

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

No publications provided

Responsible Party: Nanna Arngrim, MD, medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01750723     History of Changes
Other Study ID Numbers: H-3-2012-137
Study First Received: December 11, 2012
Last Updated: July 8, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
Acetazolamide
Headache
Migraine

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014