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Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans

Primary Purpose

Headache, Migraine

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GLP-1 peptide
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache, Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Criteria for the healthy volunteers group

Inclusion Criteria:

  • Healthy men/women.
  • Age 18 to 60 years old.
  • Weight 50 to 100 kg.

Exclusion Criteria:

  • 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.

Criteria for the migraine patients group

Inclusion Criteria:

  • 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:

  • 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.

Sites / Locations

  • Dansk HovedpinecenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GLP-1

Placebo

Arm Description

Receive intravenous infusion of GLP-1.

Receive intravenous infusion of saline.

Outcomes

Primary Outcome Measures

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)
Headache intensity
Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )

Secondary Outcome Measures

blood pressure
Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes
Facial skin perfusion
Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.
Heart rate
heart rate will be measured every 10 minutes
Plasma glucose
Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser

Full Information

First Posted
January 9, 2020
Last Updated
January 15, 2020
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT04232605
Brief Title
Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
Official Title
Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Active Comparator
Arm Description
Receive intravenous infusion of GLP-1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receive intravenous infusion of saline.
Intervention Type
Other
Intervention Name(s)
GLP-1 peptide
Intervention Description
Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Receive intravenous infusion saline
Primary Outcome Measure Information:
Title
Vasodilation
Description
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)
Time Frame
120 minutes
Title
Headache intensity
Description
Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
blood pressure
Description
Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes
Time Frame
120 minutes
Title
Facial skin perfusion
Description
Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.
Time Frame
120 minutes
Title
Heart rate
Description
heart rate will be measured every 10 minutes
Time Frame
120 minutes
Title
Plasma glucose
Description
Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Criteria for the healthy volunteers group Inclusion Criteria: Healthy men/women. Age 18 to 60 years old. Weight 50 to 100 kg. Exclusion Criteria: 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. Criteria for the migraine patients group Inclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashmat Ghanizada, MD
Phone
38633470
Email
hashmat.ghanizada@regionh.dk
Facility Information:
Facility Name
Dansk Hovedpinecenter
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans

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