Hemodynamics of Cranial ArteriesNCT03886922
The Hemodynamics Effect of Glibenclamide on Levcromakalim Assessed by High Resolution Magnetic Resonance Angiography (MRA) Technique in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
A study testing Levcromakalim and Saline in people with Hemodynamics of Cranial Arteries and Headache, run by Danish Headache Center at 2 sites in Denmark.
Trial summary
To investigate the effect of levcromakalim/placebo infusion on cranial arteries 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?
- Levcromakalim and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Apr 2019to 30 Aug 2023
- 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
- Contraindications for MRI scan.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Danish headache center
Glostrup Municipality, Copenhagen, 2600
Mohammad A Al-Karagholi, 31191647, mahdi.alkaragholi@gmail.com
- Recruiting
Mohammad Al-Mahdi Al-Karagholi
København S, Danmark, 2300
Mohammad A Al-Karagholi, 31191647, mahdi.alkaragholi@gmail.com
About this study
Official title: The Hemodynamics Effect of Levcromakalim After Glibenclamide Administration Assessed by High Resolution MRA Technique in a Randomized, Double-blind, Cross-over and Placebo-controlled Study With Healthy Volunteers.
To investigate the effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.
Read the detailed description
15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration.
The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration.
Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.
- Being tested
- Levcromakalim, Saline
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.
SalineDrug
Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.
| Study group | Role | What they receive |
|---|---|---|
| Glibenclamide and Levcromakalim | Active comparator | Participants will receive levcromakalim infusion after glibenclamide administration Receives: Drug: Levcromakalim |
| Glibenclamide and Saline | Active comparator | Participants will receive placebo infusion after glibenclamide administration Receives: Drug: Saline |
| Placebo | Sham comparator | Participants will receive placebo infusion after placebo administration. Receives: Drug: Saline |
| Levcromakalim and Glibenclamide | Active comparator | Participants will receive levcromakalim infusion before glibenclamide administration. Receives: Drug: Levcromakalim |
| Levcromakalim and Placebo | Active comparator | Participants will receive levcromakalim infusion before placebo administration. Receives: Drug: Levcromakalim; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)
Measured: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
Changes in Cerebral blood flow
Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes
Measured: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
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 (-10 min) and after (12 hours) glibenclamide administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 15 participants (estimated)
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
- NCT03886922
- Sponsor's protocol ID
- Glibenclamide H-18052188
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Karagholi MA, Ghanizada H, Kokoti L, Paulsen JS, Hansen JM, Ashina M. Effect of KATP channel blocker glibenclamide on levcromakalim-induced headache. Cephalalgia. 2020 Sep;40(10):1045-1054. doi: 10.1177/0333102420949863. Epub 2020 Aug 17.
PubMed 32806954
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamics Effect of Levcromakalim After Glibenclamide Administration Assessed by High Resolution MRA Technique in a Randomized, Double-blind, Cross-over and Placebo-controlled Study With Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03886922
- Acronym / sponsor ID
- Glibenclamide H-18052188
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 22 Mar 2019 (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 effect of levcromakalim/placebo infusion on cranial arteries after glibenclamide administration.
Detailed description
15 healthy participants will randomly be allocated to receive levcromakalim or placebo on to different days before and after oral glibenclamide administration.
The aim of the study is to investigate the effect of levcromakalim/placebo infusion on cranial arteries before and after glibenclamide administration.
Repeated magnetic resonance angiography (MRA) measurements covering the middle meningeal artery (MMA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide administration and levcromakalim/placebo infusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Glibenclamide and Levcromakalim | Active comparator | Drug: LevcromakalimParticipants will receive levcromakalim infusion after glibenclamide administration |
| Glibenclamide and Saline | Active comparator | Drug: SalineParticipants will receive placebo infusion after glibenclamide administration |
| Placebo | Sham comparator | Drug: SalineParticipants will receive placebo infusion after placebo administration. |
| Levcromakalim and Glibenclamide | Active comparator | Drug: LevcromakalimParticipants will receive levcromakalim infusion before glibenclamide administration. |
| Levcromakalim and Placebo | Active comparator | Drug: Levcromakalim, Drug: SalineParticipants will receive levcromakalim infusion before 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 (4 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
- Contraindications for MRI scan.
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 |
|---|---|---|
| LevcromakalimIntravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration. | Drug | Glibenclamide and Levcromakalim, Levcromakalim and Glibenclamide, Levcromakalim and Placebo |
| SalineIntravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration. | Drug | Glibenclamide and Saline, Levcromakalim and Placebo, Placebo |
Primary outcome
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
Time frame: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
Repeated MRA measurements covering the diameter of MMA , STA and MCA before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)
Changes in Cerebral blood flow
Time frame: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion
Repeated MRA measurements covering the blood flow before and after glibenclamide administration and levcromakalim/placebo infusion measured by centimeter (cm)/minutes
Headache
Time frame: Time of headache measurements is from before (-10 min) and after (12 hours) glibenclamide administration.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 32806954Al-Karagholi MA, Ghanizada H, Kokoti L, Paulsen JS, Hansen JM, Ashina M. Effect of KATP channel blocker glibenclamide on levcromakalim-induced headache. Cephalalgia. 2020 Sep;40(10):1045-1054. doi: 10.1177/0333102420949863. Epub 2020 Aug 17.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levcromakalim and Saline 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 4 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the middle meningeal artery (MMA), superficiel temporal artery (STA) and middle cerebral artery (MCA) (time frame: Time of measurements is baseline, 1 hour after glibenclamide administration, 2 hour after glibenclamide administration, 20 minutes after levcromakalim infusion, 60 min after levcromakalim infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886922, which also lists 1 linked publication.
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 7 Jul 2022.