Hemodynamics of Cranial ArteriesNCT04231617
The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers
A study testing glibenclamide and CGRP infusion in people with Hemodynamics of Cranial Arteries and Headache, run by Danish Headache Center at 2 sites in Denmark.
Trial summary
To investigate the hemodynamic effects of CGRP after glibenclamide administration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics of Cranial Arteries, Headache, Cerebral Blood Flow
- What is being tested?
- glibenclamide and CGRP infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Jan 2020to 1 Sep 2020
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception
Who cannot join
- A history of serious somatic disease
- Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- Daily intake of any medication except contraceptives
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish headache center
Glostrup Municipality, Copenhagen, 2600
Mohammad Al-Mahdi Al-Karagholi
København S, Danmark, 2300
About this study
Official title: The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
To investigate the hemodynamic effects of CGRP after glibenclamide administration.
Read the detailed description
20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.
- Being tested
- glibenclamide, CGRP infusion, Placebo
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glibenclamideDrug
Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
CGRP infusionDrug
CGRP infusion
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| CGRP and glibenclamide | Active comparator | Participants will recieve CGRP infusion after glibenclamide/placebo administration Receives: Drug: glibenclamide; Drug: CGRP infusion |
| CGRP and placebo | Active comparator | Participants will recieve CGRP infusion after glibenclamide/placebo administration Receives: Drug: CGRP infusion; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)
Measured: Time of measurements is baseline and repeatedly every 20 min for 240 min.
Secondary outcomes (1)
Headache
Headache intensity will be recorded by numerical rating scale (NRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache).
Measured: Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamics of Cranial ArteriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231617
- Sponsor's protocol ID
- H-19065735
- Status last verified
- Sep 2020
- First submitted
- 14 Jan 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04231617
- Acronym / sponsor ID
- H-19065735
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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 the hemodynamic effects of CGRP after glibenclamide administration.
Detailed description
20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| CGRP and glibenclamide | Active comparator | Drug: glibenclamide, Drug: CGRP infusionParticipants will recieve CGRP infusion after glibenclamide/placebo administration |
| CGRP and placebo | Active comparator | Drug: CGRP infusion, Drug: PlaceboParticipants will recieve CGRP infusion after glibenclamide/placebo administration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception
Key exclusion criteria (3 listed)
- A history of serious somatic disease
- Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- Daily intake of any medication except contraceptives
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 |
|---|---|---|
| glibenclamideOral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration . | Drug | CGRP and glibenclamide |
| CGRP infusionCGRP infusion | Drug | CGRP and glibenclamide, CGRP and placebo |
| Placeboplacebo | Drug | CGRP and placebo |
Primary outcome
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Time frame: Time of measurements is baseline and repeatedly every 20 min for 240 min.
Repeated measurements covering the diameter of RA , STA and MCA before and after glibenclamide/placebo administration and CGRP infusion measured by centimeter (cm)
1 secondary outcome
Headache
Time frame: Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.
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 9 Sep 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glibenclamide and CGRP infusion in people with Hemodynamics of Cranial Arteries and Headache, run by Danish Headache Center at 2 sites 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 3 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) (time frame: Time of measurements is baseline and repeatedly every 20 min for 240 min.). It is what the study was designed to measure, not a finding.
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 9 Sep 2020.