NCT04232605

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 9, 2020

Last Update Submit

January 15, 2020

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • blood pressure

    120 minutes

  • Facial skin perfusion

    120 minutes

  • Heart rate

    120 minutes

  • Plasma glucose

    120 minutes

Study Arms (2)

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

GLP-1 peptideOTHER

Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.

GLP-1
PlaceboOTHER

Receive intravenous infusion saline

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dansk Hovedpinecenter

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

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

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Hashmat Ghanizada, MD

CONTACT

38633470hashmat.ghanizada@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 18, 2020

Study Start

January 9, 2020

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DK(1)