MigraineNCT04960657
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
A study testing glibenclamide and PACAP38 in people with Migraine and Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To investigate the hemodynamic effects of PACAP38 after glibenclamide administration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- glibenclamide and PACAP38
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Oct 2020to 19 Mar 2021
- 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 age must use adequate contraception
Who cannot join
- A history of serious somatic or psychiatric disease
- Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)
- Daily intake of any medication except contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.
Read the detailed description
22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration
- Being tested
- glibenclamide, PACAP38
- Keywords
- Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents
- Medical subject headings
- Migraine Disorders, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glibenclamideDrug
Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
PACAP38Drug
Also called Pituitary adenylate cyclase activating polypeptide-38
PACAP38 infusion
| Study group | Role | What they receive |
|---|---|---|
| PACAP38 and glibenclamide | Active comparator | Participants will receive glibenclamide after PACAP38 infusion Receives: Drug: glibenclamide; Drug: PACAP38 |
| PACAP38 and placebo | Active comparator | Participants will receive placebo after PACAP38 infusion Receives: Drug: glibenclamide; Drug: PACAP38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 minutes) and up to 12 hours after PACAP38 infusion
Secondary outcomes (1)
Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).
Repeated measurements covering the diameter of RA, STA and MCA before and after PACAP38 infusion and glibenclamide/placebo administration measured by centimeter (cm)
Measured: Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start20 Oct 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Kokoti, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960657
- Sponsor's protocol ID
- H19065735
- Status last verified
- Jul 2021
- First submitted
- 24 May 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04960657
- Acronym / sponsor ID
- H19065735
- Keywords
- Glyburide, Physiological Effects of Drugs, Hypoglycemic Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 14 Jul 2021 (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 PACAP38 after glibenclamide administration.
Detailed description
22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration
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 |
|---|---|---|
| PACAP38 and glibenclamide | Active comparator | Drug: glibenclamide, Drug: PACAP38Participants will receive glibenclamide after PACAP38 infusion |
| PACAP38 and placebo | Active comparator | Drug: glibenclamide, Drug: PACAP38Participants will receive placebo after PACAP38 infusion |
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 age must use adequate contraception
Key exclusion criteria (3 listed)
- A history of serious somatic or psychiatric disease
- Migraine or any other type of headache (except episodic tension-type headache less than 5 days per 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/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration . | Drug | PACAP38 and glibenclamide, PACAP38 and placebo |
| PACAP38Also: Pituitary adenylate cyclase activating polypeptide-38PACAP38 infusion | Drug | PACAP38 and glibenclamide, PACAP38 and placebo |
Primary outcome
Headache
Time frame: Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion
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).
1 secondary outcome
Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).
Time frame: Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.
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 14 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glibenclamide and PACAP38 in people with Migraine and 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 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 14 Jul 2021. 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.
What does the primary outcome measure?
Headache (time frame: Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion). 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 14 Jul 2021.