Headache, MigraineNCT04232605
Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
A study testing GLP-1 peptide in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- GLP-1 peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Jan 2020to 1 Jan 2022
- 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 men/women.
- Age 18 to 60 years old.
- Weight 50 to 100 kg.
- Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
- Age 18 to 60 years old.
- Weight 50 to 100 kg.
Who cannot join
- Tension headache more than 5 days a month in the preceding year.
- All other primary headache types.
- Headache on the examination day or within 48 hours before infusion of the study drug.
- Smoking.
- Daily intake of medicine of any kind except for peroral contraceptives.
- Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
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- Hypertension or hypotension.
- Coronary heart disease of any kind, as well as cerebrovascular disease.
- Pulmonary disease.
- Allergy to contents in the study drug.
- Psychiatric disease or substance abuse.
- Disease of any kind which the examining doctor deems relevant for participation in the study.
- Renouncing the right to information concerning own health.
- Criteria for the migraine patients group
- Tension headache more than 5 days a month in the preceding year.
- All other primary headache types.
- Headache on the examination day or within 48 hours before infusion of the study drug.
- Smoking.
- Daily intake of medicine of any kind except for peroral contraceptives.
- Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
- Hypertension or hypotension.
- Coronary heart disease of any kind, as well as cerebrovascular disease.
- Pulmonary disease.
- Allergy to contents in the study drug.
- Psychiatric disease or substance abuse.
- Disease of any kind which the examining doctor deems relevant for participation in the study.
- Renouncing the right to information concerning own health.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dansk Hovedpinecenter
Glostrup Municipality, 2600
About this study
Official title: Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients
Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.
Read the detailed description
The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.
- Conditions
- Headache, Migraine
- Being tested
- GLP-1 peptide, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 peptideOther
Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
PlaceboOther
Receive intravenous infusion saline
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Active comparator | Receive intravenous infusion of GLP-1. Receives: Other: GLP-1 peptide |
| Placebo | Placebo comparator | Receive intravenous infusion of saline. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasodilation
Difference in circumference (in millimeter) of intra - and extracranial blood vessels before and after GLP-1 or placebo infusion, measured by transcranial doppler and ultrasound (Derma scan) at 10 specific time points (-10, 10, 20, 30, 40, 50, 60, 80, 100, and 120 minutes)
Measured: 120 minutes
Headache intensity
Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )
Measured: 12 hours
Secondary outcomes (4)
blood pressure
Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes
Measured: 120 minutes
Facial skin perfusion
Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.
Measured: 120 minutes
Heart rate
heart rate will be measured every 10 minutes
Measured: 120 minutes
Plasma glucose
Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser
Measured: 120 minutes
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 start9 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, 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
- Phase one: In a randomized, single-blind, multiple-ascending-dose finding pilot study we investigate the safety and tolerability of GLP-1 on three healthy volunteers. The following GLP-1 doses will be given intravenously ( 1.5, 2.0 and 2.5 picomol/kg/min) over 20 min. The dose with considerable dilatory effect will be chosen for main study. Phase 2 and 3:The study is a double-blinded, placebo-controlled, randomized crossover study. It involves two arms, GLP-1 and placebo. Each participant will in a randomized order receive placebo or GLP-1 intravenous infusion over 20 min on the two experiment days. The study consists of two separate substudies, one for healthy volunteers and one for migraine patients. The substudies are otherwise identical.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashmat Ghanizada, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232605
- Sponsor's protocol ID
- H-19037051
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 18 Jan 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients
- ClinicalTrials.gov ID
- NCT04232605
- Acronym / sponsor ID
- H-19037051
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- 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.
Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.
Detailed description
The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase one: In a randomized, single-blind, multiple-ascending-dose finding pilot study we investigate the safety and tolerability of GLP-1 on three healthy volunteers. The following GLP-1 doses will be given intravenously ( 1.5, 2.0 and 2.5 picomol/kg/min) over 20 min. The dose with considerable dilatory effect will be chosen for main study. Phase 2 and 3:The study is a double-blinded, placebo-controlled, randomized crossover study. It involves two arms, GLP-1 and placebo. Each participant will in a randomized order receive placebo or GLP-1 intravenous infusion over 20 min on the two experiment days. The study consists of two separate substudies, one for healthy volunteers and one for migraine patients. The substudies are otherwise identical.
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Active comparator | Other: GLP-1 peptideReceive intravenous infusion of GLP-1. |
| Placebo | Placebo comparator | Other: PlaceboReceive intravenous infusion of saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men/women.
- Age 18 to 60 years old.
- Weight 50 to 100 kg.
- Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
- Age 18 to 60 years old.
Key exclusion criteria (27 listed)
- Tension headache more than 5 days a month in the preceding year.
- All other primary headache types.
- Headache on the examination day or within 48 hours before infusion of the study drug.
- Smoking.
- Daily intake of medicine of any kind except for peroral 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 |
|---|---|---|
| GLP-1 peptideReceive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study. | Other | GLP-1 |
| PlaceboReceive intravenous infusion saline | Other | Placebo |
Primary outcome
Vasodilation
Time frame: 120 minutes
Difference in circumference (in millimeter) of intra - and extracranial blood vessels before and after GLP-1 or placebo infusion, measured by transcranial doppler and ultrasound (Derma scan) at 10 specific time points (-10, 10, 20, 30, 40, 50, 60, 80, 100, and 120 minutes)
Headache intensity
Time frame: 12 hours
Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )
4 secondary outcomes
blood pressure
Time frame: 120 minutes
Facial skin perfusion
Time frame: 120 minutes
Heart rate
Time frame: 120 minutes
Plasma glucose
Time frame: 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 peptide in people with Headache, Migraine, 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 6 inclusion and 27 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 18 Jan 2020. 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. 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?
Contact Hashmat Ghanizada, MD (38633470, hashmat.ghanizada@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasodilation (time frame: 120 minutes). The study lists 2 primary outcomes in all. 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 18 Jan 2020.