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

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ClinicalTrials.gov Identifier: NCT03787238
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

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.


Condition or disease Intervention/treatment Phase
Migraine Device: non-invasive vagus nerve stimulation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: non-invasive Vagus Nerve Stimulation
nVNS (non-invasive vagus nerve stimulation) treatment with the gammaCore Sapphire device and standard of care
Device: non-invasive vagus nerve stimulation
non-invasive vagus nerve stimulation using the gammaCore Sapphire device

No Intervention: Standard of Care
Standard of Care treatment



Primary Outcome Measures :
  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 [ Time Frame: The last four weeks in the randomization period compared to 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


Secondary Outcome Measures :
  1. 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 [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
    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

  2. Reduction in number of migraine days and headache days (separately) [ Time Frame: 12 week randomised period ]
    Reduction in number of migraine days and headache days (separately) during weeks 1 through 4, 5 through 8 in the 12 week randomised period

  3. Rate of responders for the nVNS group compared to the standard of care group. [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
    Rate of responders (mean reduction in migraine days during the last four weeks in the twelve-week randomization period compared to the four-week run-in period dichotomized as <25% vs. ≥25%, <50% vs ≥50% and <75% vs ≥75%, separately) for the nVNS group compared to the standard of care group.

  4. Acute treatment response for nVNS and standard of care therapies [ Time Frame: 12 week randomised period ]
    Acute treatment response for nVNS and standard of care therapies at 30, 60 and 120 minutes post-treatment, for all treated migraine attacks in the twelve-week randomized period

  5. Consistency of response [ Time Frame: 12 week randomised period ]
    Consistency of response as defined as the percentage of subjects who achieve treatment response in 25%, 50% and 75% or greater of their attacks, in subjects treating at least two attacks, for nVNS and standard of care therapies for all treated migraine attacks during the randomized period

  6. Safety and tolerability of nVNS as measured by adverse events [ Time Frame: 12 week randomised period ]
    Safety and tolerability of nVNS as measured by adverse events


Other Outcome Measures:
  1. Change in acute headache medication use [ Time Frame: 12 week randomization period compared to the four week run-in period ]
    Change in acute headache medication use (proportion of attacks with acute medication use prior to or at 120 minutes post-treatment) for all treated attacks in the twelve-week randomized period compared to the four week run-in period in the nVNS group

  2. Presence or absence of nausea, vomiting, photophobia, phonophobia [ Time Frame: 12 week randomised period ]
    Presence or absence of nausea, vomiting, photophobia, phonophobia at 0, 30, 60 and 120 minutes post treatment for nVNS and standard of care therapies for all treated migraine attacks in the randomized period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  • 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).
  • Has a history of seizures (within the last 1 year).
  • Has a known or suspicion of substance abuse or addiction (within the last 1 year).
  • Has initiated medications for migraine prophylaxis in the previous 30 days, or in the case of Botulinum toxin and monoclonal antibodies against CGRP injections in the previous 90 days.
  • Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for the prophylaxis of migraine.
  • Is pregnant or of childbearing years and is unwilling to use and accepted form of birth control (condom or contraceptive pill).
  • Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  • Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner).
  • Has previously used the gammaCore device within the last 3 months.

Information from the National Library of Medicine

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): NCT03787238


Contacts
Contact: Alexandra Sinclair, MD 00 44 (0)121 414 8857 A.B.Sinclair@bham.ac.uk

Locations
Denmark
Danish Headache Center
Glostrup, Denmark, DK-2600
Germany
CTC, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, D-20251
Migräne- und Kopfschmerzklinik Königstein
Königstein im Taunus, Germany, D-61462
Klinik für Neurologie, Ludwig-Maximilliams-Universität, Klinikum Grosshadern
München, Germany, D-81377
Klinik und Poliklinik für Neurologie, Universitätsmedizin Rostock Not yet recruiting
Rostock, Germany, D-18147
Contact: Tim Jurgens, MD    +49 381 494 9511    tim.juergens@med.uni-rostock.de   
Principal Investigator: Tim Jurgens, MD         
Italy
National Neurological Institute C. Mondino Foundatio Not yet recruiting
Mondino, Pavia, Italy, 27100
Contact: Cristina Tassorelli, Prof.    +39 038 238 0390    cristina.tassorelli@unipv.it   
Principal Investigator: Cristina Tassorelli, Prof,         
U.O. Neurologia III - Cefalee e Neuroalgologia, Fondazione IRCCS Istituto
Milan, Italy, 20133
Netherlands
Leiden University Medical Center, Neurology Department, K5-Q-104
Leiden, Netherlands, 2333 ZA
Spain
Headache Unit, University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Servicio de Neurologia, Hospital Ruber Internacional
Madrid, Spain, 28034
Servicio de Neurologia, Clinica Universidad de Navarra
Pamplona, Spain, ES-31008
Servicio de Neurologia, Hospital Clinico Universitario de Valencia
Valencia, Spain, ES-46010
United Kingdom
Hull Royal Infirmary, Neurology Department
Hull, East Yorkshire, United Kingdom, HU3 2JZ
University of Birmingham Not yet recruiting
Birmingham, United Kingdom, B15 2TT
Contact: Alexandra Sinclair, MD    00 44 121 414 8857    A.B.Sinclair@bham.ac.uk   
Principal Investigator: Alexandra Sinclair, MD         
Queen Elizabeth Hospital Queen
Gateshead, United Kingdom, NE9 6SX
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Sponsors and Collaborators
ElectroCore INC
Investigators
Principal Investigator: Alexandra Sinclair, MD University of Birmingham

Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT03787238     History of Changes
Other Study ID Numbers: GM-18
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases