MigraineREALNCT03787238
A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)
A study testing non-invasive vagus nerve stimulation in people with Migraine, run by ElectroCore INC at 17 sites in 5 countries.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- non-invasive vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 15 May 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)).
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- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany4 sites
CTC, University Medical Center Hamburg-Eppendorf
Hamburg, D-20251
Migräne- und Kopfschmerzklinik Königstein
Königstein im Taunus, D-61462
Klinik für Neurologie, Ludwig-Maximilliams-Universität, Klinikum Grosshadern
München, D-81377
Klinik und Poliklinik für Neurologie, Universitätsmedizin Rostock
Rostock, D-18147
Italy4 sites
U.O. Neurologia III - Cefalee e Neuroalgologia, Fondazione IRCCS Istituto
Milan, 20133
National Neurological Institute C. Mondino Foundatio
Mondino, Pavia, 27100
Department of Neurological, Motor and Sensorial Sciences, IRCCS San Raffaele
Rome, 00163
University of Turin
Turin, 10124
Spain4 sites
Headache Unit, University Hospital Vall d'Hebron
Barcelona, 08035
Servicio de Neurologia, Hospital Ruber Internacional
Madrid, 28034
Servicio de Neurologia, Clinica Universidad de Navarra
Pamplona, ES-31008
Servicio de Neurologia, Hospital Clinico Universitario de Valencia
Valencia, ES-46010
United Kingdom4 sites
University of Birmingham
Birmingham, B15 2TT
Queen Elizabeth Hospital Queen
Gateshead, NE9 6SX
Hull Royal Infirmary, Neurology Department
Hull, East Yorkshire, HU3 2JZ
Sunderland Royal Hospital
Sunderland, SR4 7TP
About this study
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)
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.
.
Read the 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.
- Conditions
- Migraine
- Being tested
- non-invasive vagus nerve stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive vagus nerve stimulationDevice
non-invasive vagus nerve stimulation using the gammaCore Sapphire device
| Study group | Role | What they receive |
|---|---|---|
| non-invasive Vagus Nerve Stimulation | Experimental | nVNS (non-invasive vagus nerve stimulation) treatment with the gammaCore Sapphire device and standard of care Receives: Device: non-invasive vagus nerve stimulation |
| Standard of Care | No intervention | Standard of Care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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)
Reduction in number of migraine days and headache days (separately) during weeks 1 through 4, 5 through 8 in the 12 week randomised period
Measured: 12 week randomised period
Rate of responders for the nVNS group compared to the standard of care group.
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.
Measured: 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
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
Measured: 12 week randomised period
Consistency of response
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
Measured: 12 week randomised period
Safety and tolerability of nVNS as measured by adverse events
Safety and tolerability of nVNS as measured by adverse events
Measured: 12 week randomised period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start15 May 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra Sinclair, MD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787238
- Sponsor's protocol ID
- GM-18
- Acronym
- REAL
- Status last verified
- Jun 2019
- First submitted
- 20 Dec 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03787238
- Acronym / sponsor ID
- REAL / GM-18
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-invasive Vagus Nerve Stimulation | Experimental | Device: non-invasive vagus nerve stimulationnVNS (non-invasive vagus nerve stimulation) treatment with the gammaCore Sapphire device and standard of care |
| Standard of Care | No intervention | –Standard of Care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive vagus nerve stimulationnon-invasive vagus nerve stimulation using the gammaCore Sapphire device | Device | non-invasive Vagus Nerve Stimulation |
Primary outcome
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
6 secondary outcomes
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 migraine days and headache days (separately)
Time frame: 12 week randomised period
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.
Acute treatment response for nVNS and standard of care therapies
Time frame: 12 week randomised period
Consistency of response
Time frame: 12 week randomised period
Safety and tolerability of nVNS as measured by adverse events
Time frame: 12 week randomised period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Sinclair, MD principal investigator
University of Birmingham
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive vagus nerve stimulation in people with Migraine, run by ElectroCore INC at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Italy, Spain, United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.