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A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL) | Clinical Trials | Clareo Health

WITHDRAWNNA

A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)

GM-18 - A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine Using Open Label Non-invasive Vagal Nerve Stimulation, Versus Standard of Care (REAL)

NCT03787238•ElectroCore INC

View on ClinicalTrials.gov

Summary

This is a randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. .

Detailed Description

A randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. Eligible subjects will participate in a 4 week run-in period after which they will be randomized (1:1) to either nVNS and standard of care (nVNS group) or standard of care (SOC group) for 12 weeks. The nVNS group will use the nVNS device preventatively and acutely for the treatment of migraine. The SOC group will continue to use their regular standard of care migraine treatment medications for the duration of the 12 week randomized period.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is 18 years of age or above.
•Has been previously diagnosed with episodic or chronic migraine (with or without aura) in accordance with the ICHD-3 Classification criteria.
•Experience at least 6 and no more than 24 headache days per month and a minimum of 4 migraine attacks per month (over the last 3 months).
•Has age of onset of migraine less than 50 years old.
•Stable regime for any migraine preventative medications for the last 3 months and agrees to maintain stable regime for duration of the study.
•Agrees to and in clinician opinion is able to use the nVNS device as intended, follow all of the requirements of the study including follow-up visit requirements, record required study data in the subject dairy, and other self-assessment questionnaires.
•Availability of internet/Web access for Web-based e-diary completion
•Is able to provide written Informed Consent.

Exclusion Criteria

•Requires use of oral or injectable steroids for concomitant medical condition that in the opinion of the investigator will interfere with the study.
•Has a history of any intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma.
•Has a structural abnormality at the nVNS treatment site (e.g. lymphadenopathy previous surgery or abnormal anatomy).
•Has pain at the nVNS treatment site (e.g. dysesthesia, neuralgia and/or cervicalgia).
•Has other significant pain problem (e.g. cancer pain or other head or facial disorder) that in the opinion of the investigator may confound the study assessments
•Has known or suspected severe cardiac disease (e.g. symptomatic coronay artery disease, prior myocardial infarction, congestive heart failure (CHF)).
•Has known or suspected severe cerebrovascular disease, (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior cartoid endarterectomy or other vascular neck surgery).
•Has known or suspected own and/or family history of cardiac disease (including but not limited to ischemic heart disease, rhythm disturbances, congenital abnormalities cardiac myopathies), or presents risk factors strongly associated with risk for developing cardiologic abnormalities that in the opinion of the investigator might compromise subjects safety using n-VNS.
•Has had a cervical vagotomy.
•Has uncontrolled high blood pressure (systolic \>160 diastolic \> 100 after 3 repeated measurements within 24 hours).
+13 more criteria

Locations (17)

Danish Headache Center

Glostrup Municipality, Denmark

CTC, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Migräne- und Kopfschmerzklinik Königstein

Königstein im Taunus, Germany

Klinik für Neurologie, Ludwig-Maximilliams-Universität, Klinikum Grosshadern

München, Germany

Klinik und Poliklinik für Neurologie, Universitätsmedizin Rostock

Rostock, Germany

National Neurological Institute C. Mondino Foundatio

Mondino, Pavia, Italy

U.O. Neurologia III - Cefalee e Neuroalgologia, Fondazione IRCCS Istituto

Milan, Italy

Department of Neurological, Motor and Sensorial Sciences, IRCCS San Raffaele

Rome, Italy

University of Turin

Turin, Italy

Headache Unit, University Hospital Vall d'Hebron

Barcelona, Spain

Key Dates

Start Date

May 15, 2019

Primary Completion Date

September 1, 2020

Completion Date

October 1, 2020

Last Updated

June 14, 2019

Conditions

Migraine

Interventions

non-invasive vagus nerve stimulation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)

Inclusion Criteria

Exclusion Criteria

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