HeadacheNCT00357864
Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow
An observational study of Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate headache score and accompanying symptoms during and after infusion of carbachol. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- carbachol
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2006to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Aged 18-40
- 50-100 kg
- Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.
Who cannot join
- 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
Show all 10Show fewer
- Headache within the last 24 hours before start of trial
- Hypertension
- Hypotension
- Respiratory or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basic Research on Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow in a Humane Experimental Headache Model
To investigate headache score and accompanying symptoms during and after infusion of carbachol.
Read the detailed description
To investigate headache score and accompanying symptoms during and after infusion of carbachol.
Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)
- Conditions
- Headache
- Being tested
- carbachol
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbacholDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startJul 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- henrik schytz, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357864
- Sponsor's protocol ID
- 2006-002462-19
- Status last verified
- Aug 2007
- First submitted
- 26 Jul 2006
- Last updated
- 30 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Research on Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow in a Humane Experimental Headache Model
- ClinicalTrials.gov ID
- NCT00357864
- Acronym / sponsor ID
- 2006-002462-19
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate headache score and accompanying symptoms during and after infusion of carbachol.
Detailed description
To investigate headache score and accompanying symptoms during and after infusion of carbachol.
Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Aged 18-40
- 50-100 kg
- Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbachol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
henrik schytz principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2007.