Text Size
Trial record 8 of 182 for:    Open Studies | "Headache"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified December 2012 by Danish Headache Center
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01750723
First received: December 11, 2012
Last updated: April 19, 2013
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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.


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750723

Contacts
Contact: Nanna Arngrim, MD 38634612 ext 0045 nanna.bjoerkbom.arngrim.01@regionh.dk
Contact: Messoud Ashina, MD 38632062 ext 0045 hovedpine@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Nanna Arngrim, MD     38 63 46 12     nanna.bjoerkbom.arngrim.01@regionh.dk    
Principal Investigator: Nanna Arngrim, MD            
Department of Neurology Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Nanna Arngrim, MD     38 63 46 12     nanna.bjoerkbom.arngrim.01@regionh.dk    
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: April 19, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
Acetazolamide
Headache
Migraine

Additional relevant MeSH terms:
Headache
Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 May 19, 2013