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

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT01750723
Collaborator
(none)
12
Enrollment
2
Locations
2
Arms
4
Duration (Months)
6
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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 Design

Study Type:
Interventional
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 :
Dec 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Headache scores [24 h]

      Comparison between Acetazolamide and placebo (saline).

    Secondary Outcome Measures

    1. Artery circumference [Baseline, 30 min and 60 min]

      Acetazolamide induced changes in intracranial artery circumference before and after infusions.

    2. Cerebral blood flow [Baseline, 30 and 60 min.]

      Acetazolamide induced changes in cerebral blood flow.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danish Headache Center Copenhagen Glostrup Denmark 2600
    2 Department of Neurology Copenhagen Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Principal Investigator: Nanna Arngrim, MD, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanna Arngrim, MD, medical doctor, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT01750723
    Other Study ID Numbers:
    • H-3-2012-137
    First Posted:
    Dec 17, 2012
    Last Update Posted:
    Jul 9, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Nanna Arngrim, MD, medical doctor, Danish Headache Center
    Acetazolamide
    Headache
    Migraine
    Additional relevant MeSH terms:
    Headache
    Acetazolamide

    Study Results

    No Results Posted as of Jul 9, 2013