Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
NCT ID: NCT04232605
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
43 participants
INTERVENTIONAL
2020-01-09
2022-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
OTHER
TRIPLE
Study Groups
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GLP-1
Receive intravenous infusion of GLP-1.
GLP-1 peptide
Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
Placebo
Receive intravenous infusion of saline.
Placebo
Receive intravenous infusion saline
Interventions
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GLP-1 peptide
Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
Placebo
Receive intravenous infusion saline
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
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.
18 Years
60 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Hashmat Ghanizada
Principal investigator
Locations
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Dansk Hovedpinecenter
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Other Identifiers
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H-19037051
Identifier Type: -
Identifier Source: org_study_id
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