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

NCT ID: NCT01750723

Last Updated: 2013-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Headache Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acetazolamide

Acetazolamide 1 g in 10 ml saline, i.v. infusion

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

1 g diluted in 10 ml saline, i.v. bolus injection.

Saline

Saline, 10 ml i.v. infusion

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Acetazolamide

1 g diluted in 10 ml saline, i.v. bolus injection.

Intervention Type DRUG

Other Intervention Names

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Diamox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Nanna Arngrim

MD, medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nanna Arngrim, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Danish Headache Center

Copenhagen, Glostrup, Denmark

Site Status

Department of Neurology

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-3-2012-137

Identifier Type: -

Identifier Source: org_study_id

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