Back to resultsAcetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Primary Purpose
Headache, Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acetazolamide
Sponsored by
About this trial
This is an interventional basic science trial for Headache focused on measuring Acetazolamide, Headache, Migraine
Eligibility 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
Sites / Locations
- Danish Headache Center
- Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acetazolamide
Saline
Arm Description
Acetazolamide 1 g in 10 ml saline, i.v. infusion
Saline, 10 ml i.v. infusion
Outcomes
Primary Outcome Measures
Headache scores
Comparison between Acetazolamide and placebo (saline).
Secondary Outcome Measures
Artery circumference
Acetazolamide induced changes in intracranial artery circumference before and after infusions.
Cerebral blood flow
Acetazolamide induced changes in cerebral blood flow.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01750723
Brief Title
Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Acetazolamide, Headache, Migraine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
Acetazolamide 1 g in 10 ml saline, i.v. infusion
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline, 10 ml i.v. infusion
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
1 g diluted in 10 ml saline, i.v. bolus injection.
Primary Outcome Measure Information:
Title
Headache scores
Description
Comparison between Acetazolamide and placebo (saline).
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Artery circumference
Description
Acetazolamide induced changes in intracranial artery circumference before and after infusions.
Time Frame
Baseline, 30 min and 60 min
Title
Cerebral blood flow
Description
Acetazolamide induced changes in cerebral blood flow.
Time Frame
Baseline, 30 and 60 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Arngrim, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Department of Neurology
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
We'll reach out to this number within 24 hrs