Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Basic Research on Acetazolamide´s Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 9, 2013
July 1, 2013
4 months
December 11, 2012
July 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache scores
Comparison between Acetazolamide and placebo (saline).
24 h
Secondary Outcomes (2)
Artery circumference
Baseline, 30 min and 60 min
Cerebral blood flow
Baseline, 30 and 60 min.
Study Arms (2)
Acetazolamide
ACTIVE COMPARATORAcetazolamide 1 g in 10 ml saline, i.v. infusion
Saline
PLACEBO COMPARATORSaline, 10 ml i.v. infusion
Interventions
1 g diluted in 10 ml saline, i.v. bolus injection.
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Aged 18-40
- Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Danish Headache Center
Copenhagen, Glostrup, 2600, Denmark
Department of Neurology
Copenhagen, Glostrup, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nanna Arngrim, MD
Danish Headache Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, medical doctor
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 17, 2012
Study Start
December 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
July 9, 2013
Record last verified: 2013-07