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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750723
• Other study ID #: H-3-2012-137
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: July 8, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• Acetazolamide
1 g diluted in 10 ml saline, i.v. bolus injection.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Glostrup
Denmark	Department of Neurology	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache scores	Comparison between Acetazolamide and placebo (saline).	24 h	No
Secondary	Artery circumference	Acetazolamide induced changes in intracranial artery circumference before and after infusions.	Baseline, 30 min and 60 min	No
Secondary	Cerebral blood flow	Acetazolamide induced changes in cerebral blood flow.	Baseline, 30 and 60 min.	No