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

Not Applicable

Completed

• Conditions: Migraine; Headache
• Interventions: Drug: Acetazolamide

• Registration Number: NCT01750723
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-17
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Headache scores	24 h	Comparison between Acetazolamide and placebo (saline).

Secondary Outcome Measures

Name	Time	Method
Artery circumference	Baseline, 30 min and 60 min	Acetazolamide induced changes in intracranial artery circumference before and after infusions.
Cerebral blood flow	Baseline, 30 and 60 min.	Acetazolamide induced changes in cerebral blood flow.

Trial Locations

Locations (2)

Department of Neurology; 🇩🇰 Copenhagen, Glostrup, Denmark

Danish Headache Center; 🇩🇰 Copenhagen, Glostrup, Denmark