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

NCT03787238 | Withdrawn FDA Device

• 1 other identifier: GM-18
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 17

Brief 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. .

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Reduction in number of migraine days during the last four weeks in the twelve-week randomized period compared with the four-week run-in period

  Reduction in number of migraine days during the last four weeks in the twelve-week randomized period compared with the four-week run-in period

  The last four weeks in the randomization period compared to the four week run-in period.

Secondary Outcomes (6)

• Reduction in number of headache days during the last four-weeks in the twelve-week randomized period compared to the four-week run-in period

  The last four weeks in the randomization period compared to the four week run-in period.

• Reduction in number of migraine days and headache days (separately)

  12 week randomised period

• Rate of responders for the nVNS group compared to the standard of care group.

  The last four weeks in the randomization period compared to the four week run-in period.

• Acute treatment response for nVNS and standard of care therapies

  12 week randomised period

• Consistency of response

  12 week randomised period

Other Outcomes (2)

• Change in acute headache medication use

  12 week randomization period compared to the four week run-in period

• Presence or absence of nausea, vomiting, photophobia, phonophobia

  12 week randomised period

Study Arms (2)

non-invasive Vagus Nerve Stimulation

EXPERIMENTAL

nVNS (non-invasive vagus nerve stimulation) treatment with the gammaCore Sapphire device and standard of care

Device: non-invasive vagus nerve stimulation

Standard of Care

NO INTERVENTION

Standard of Care treatment

Interventions

non-invasive vagus nerve stimulation DEVICE

non-invasive vagus nerve stimulation using the gammaCore Sapphire device

non-invasive Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, Spehnopalatine ganglion stimulator or Occiptial nerve stimulator).
• Has been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site (e.g. in the head, neck of thorax).
• Presents a suspicion of secondary headache.
• Previous diagnosis of medication overuse headache within the last 3 months
• Has a history of syncope (within the last 1 year).

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (17)

Danish Headache Center

Glostrup Municipality, DK-2600, Denmark

Location

CTC, University Medical Center Hamburg-Eppendorf

Hamburg, D-20251, Germany

Location

Migräne- und Kopfschmerzklinik Königstein

Königstein im Taunus, D-61462, Germany

Location

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

München, D-81377, Germany

Location

Klinik und Poliklinik für Neurologie, Universitätsmedizin Rostock

Rostock, D-18147, Germany

Location

National Neurological Institute C. Mondino Foundatio

Mondino, Pavia, 27100, Italy

Location

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

Milan, 20133, Italy

Location

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

Rome, 00163, Italy

Location

University of Turin

Turin, 10124, Italy

Location

Headache Unit, University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Servicio de Neurologia, Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Servicio de Neurologia, Clinica Universidad de Navarra

Pamplona, ES-31008, Spain

Location

Servicio de Neurologia, Hospital Clinico Universitario de Valencia

Valencia, ES-46010, Spain

Location

Hull Royal Infirmary, Neurology Department

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Queen Elizabeth Hospital Queen

Gateshead, NE9 6SX, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexandra Sinclair, MD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: May 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

ES (4); GB (4); IT (4); DK (1); DE (4)