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Endothelin-1 as a Potential Trigger of Migraine Aura

NCT ID: NCT02906085

Last Updated: 2019-12-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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One third of migraine patients experience aura, i.e. dramatic, transient neurological symptoms, most often in the form of visual disturbances, that usually appear before the onset of migraine headache. The likely underlying mechanism of aura is known as cortical spreading depression, a wave of changes in electrical activity that slowly spreads in the outermost layer of the brain. It is currently not known what causes the aura to initiate in patients or what the relationship is between aura and migraine headache, e.g. if treatment targeted at aura mechanisms will prevent subsequent headache. Due to the short-lasting and unpredictable nature of aura, the only possible approach for systematic investigations is to experimentally trigger aura, but currently no method for aura-triggering is available.

The overall goal of the proposed project is to reveal the earliest mechanisms of the migraine attack by investigating the initiating factors of aura in the migraine brain.

Current animal evidence indicates that infusion of endothelin-1 (ET-1), a naturally occurring signaling molecule released from blood vessels, is safe and very likely to trigger migraine aura in patients.

In this project the investigators aim to study the effects of ET-1 on the human brain, to investigate aura-inducing effects of ET-1 in patients and to develop a safe and reliable method for the experimental induction of migraine aura using ET-1.

Detailed Description

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Conditions

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Migraine With Aura

Keywords

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[C10.228.140.546.399.750.250]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Endothelin-1

Intravenous infusion of pharmaceutical grade human endothelin-1

Group Type EXPERIMENTAL

Endothelin-1

Intervention Type DRUG

Placebo

Intravenous infusion of placebo (isotonic saline)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Isotonic saline

Interventions

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Endothelin-1

Intervention Type DRUG

Placebo

Isotonic saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 40 years
* Diagnosis of migraine with typical aura (patient group only)
* Attacks of migraine with aura at least once per month on average (patient group only)
* No history or family history of migraine (healthy subject group only)
* Use of safe contraception (women of fertile age only)

Exclusion Criteria

* Tension-type headache more than one day per month on average
* Any other primary headache disorder
* Daily intake of medication
* Daily smoking during the past 5 years
* Pregnant or breastfeeding women
* Hypertension on the experimental day (systolic BP\>150 mmHg or diastolic BP\> 100 mmHg)
* History of any cardiovascular disease including cerebrovascular disease
* History of diabetes or hypercholesterolemia
* ECG changes suggestive of ischemia
* Contraindications of MRI
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Anders Hougaard

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-16022143

Identifier Type: -

Identifier Source: org_study_id