Endothelin-1 as a Potential Trigger of Migraine Aura
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|ClinicalTrials.gov Identifier: NCT02906085|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : December 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine With Aura||Drug: Endothelin-1 Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigations of the Endogenous Vasoconstrictor and Neuromodulator Peptide Endothelin-1 as a Potential Trigger of Migraine Aura|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2019|
Intravenous infusion of pharmaceutical grade human endothelin-1
Placebo Comparator: Placebo
Intravenous infusion of placebo (isotonic saline)
- Occurrence of migraine aura [ Time Frame: 0-24 hours ]
- Cerebral vasoconstriction: MR angiography [ Time Frame: 0-30 ]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.
- Change in cerebral blood flow: Phase contrast mapping [ Time Frame: 0-30 minutes ]Cerebral blood flow (perfusion, ml/100 g/min) measured before and after intervention using MRI phase contrast mapping (measure of global brain perfusion). This type of investigation will be carried out in healthy subjects only.
- Change in cerebral blood flow: Arterial spin labeling [ Time Frame: 0-30 minutes ]Regional cerebral blood flow (perfusion, ml/100g/min) measured before and after intervention using MRI pseudo-continous arterial spin labelling at 3 tesla. This type of investigation will be carried out in healthy subjects only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906085
|Danish Headache Center|
|Glostrup, Denmark, 2600|