Endothelin-1 as a Potential Trigger of Migraine Aura | NCT02906085

Studies
Endothelin-1 as a Potential Trigger of Migraine Aura

NCT02906085

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Dec 12, 2019Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Migraine With Aura

Interventions

Endothelin-1
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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

May 2018Actual

Completion Date

Dec 2019Estimated

First Submitted Date

Sep 3, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 19, 2016Estimated

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

Dec 10, 2019

Last Update Posted Date

Dec 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anders Hougaard, MD, PhD, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endothelin-1	Experimental	Intravenous infusion of pharmaceutical grade human endothelin-1	Drug: Endothelin-1
Placebo	Placebo Comparator	Intravenous infusion of placebo (isotonic saline)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endothelin-1	Drug		Endothelin-1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of migraine aura		0-24 hours

Secondary Outcomes

Measure	Description	Time Frame
Cerebral vasoconstriction: MR angiography	Time of flight arteriography using 3 tesla MRI (healthy subjects). Arterial diameters and circumferences (mm) will be measured from the resulting angiography images. This type of investigation will be carried out in healthy subjects only.	0-30
Change in cerebral blood flow: Phase contrast mapping

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center		Glostrup Municipality		2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020325	Migraine with Aura

Ancestor Terms

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019332	Endothelin-1

Ancestor Terms

ID	Term
D016232	Endothelins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided