Investigation of Vasodilation and Intensity of Headache T... | NCT04232605

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

NCT04232605

Sponsor

Danish Headache Center

Status

Unknown status

Last Update Posted

Jan 18, 2020Actual

Enrollment

43Estimated

Phase

Not Applicable

Conditions

Headache, Migraine

Interventions

GLP-1 peptide
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jan 9, 2020

First Submission Date that Met QC Criteria

Jan 15, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2020

Last Update Posted Date

Jan 18, 2020Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLP-1	Active Comparator	Receive intravenous infusion of GLP-1.	Other: GLP-1 peptide
Placebo	Placebo Comparator	Receive intravenous infusion of saline.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-1 peptide	Other	Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.	GLP-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	120 minutes
Headache intensity	Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )	12 hours

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes	120 minutes
Facial skin perfusion	Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hashmat Ghanizada, MD	Contact	38633470		hashmat.ghanizada@regionh.dk

Facility	Status	City	State	ZIP	Country	Contacts
Dansk Hovedpinecenter	Recruiting	Glostrup Municipality		2600	Denmark

ID	Term
D008881	Migraine Disorders

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
C000623226	glucagon-like peptide 1 (7-37)-proline, glycyl(2)-

Intervention 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.