RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks

NCT02686034 | Completed Results

• 1 other identifier: GM-16
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 10

Brief Summary

This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks

Conditions

Migraine

Keywords

Migraine; Non-invasive vagus nerve stimulation; Vagus nerve stimulation; Vagal nerve stimulation; gammaCore; episodic migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Response - No Pain

  The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment.

  2 hours post-treatment

Secondary Outcomes (4)

• Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia

  2 hours post-treatment study - period 2 (each study period was 4 weeks)

• Number of Participants With Treatment Response - No Pain or Mild Pain

  2 hours post-treatment

• Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours.

  24 and 48 hours post-treatment

• Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks

  30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks)

Other Outcomes (11)

• Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 3

  30, 60, 120 minutes; Period 3 (each study period was 4 weeks)

• Number of Migraine Attacks With Treatment Response no Pain or Mild Pain

  30, 60, 120 minutes; Study Periods 2 and 3 (each study period was 4 weeks)

• Number of Migraine Attacks With Absence of Nausea, Vomiting, Photophobia and Phonophobia

  Study Periods 2 and 3 (each study period was 4 weeks)

Study Arms (2)

gammaCore-S

ACTIVE COMPARATOR

Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve

Device: gammaCore-S

gammaCore-S Sham

SHAM COMPARATOR

Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve

Device: gammaCore-S Sham

Interventions

gammaCore-S DEVICE

At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.

Also known as: nVNS

gammaCore-S

gammaCore-S Sham DEVICE

At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.

Also known as: sham nVNS

gammaCore-S Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is 18-75 years old.
• Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta classification criteria.
• Age of onset of migraines \< 50 years old.
• Experiences between 3-8 migraine attacks per month of moderate or severe intensity, and less than 15 headache days per month over the last 6 months.
• Is able to distinguish migraine headaches from other headaches (e.g. tension type headache).
• Agrees to withhold usual acute migraine medications until 2 hours after stimulation treatment with the study device.
• Agrees not to initiate new or change existing migraine prophylaxis medication for the duration of the study, or receive nerve blocks or injections.
• Agrees not to initiate new or change existing prophylactic medication for indications other than migraine that in the opinion of the Investigator may interfere with the study objectives (e.g. antidepressant, anti-convulsant, beta blockers, etc).
• Has internet/web access for web-based e-Diary completion.
• Agrees to use the study device as intended, comply with all study requirements including treatment, follow-up visits, record required study data in the subject diary, and complete study self-assessment questionnaires.
• Is able to provide written informed consent.

You may not qualify if:

• Experiences ≥ 15 headache days per month, including migraine, tension type headache, medication overuse headache, and other types of headache as defined in the ICHD-3 Beta classification.
• Has a known history or suspicion of secondary headache.
• Has previous diagnosis of medication overuse headache (MoH), which has reverted to episodic migraine within the last 6 months.
• Has had surgical intervention for migraine prevention.
• Has had a cervical vagotomy.
• Has a structural abnormality (e.g. lymphadenopathy, neoplasm, previous surgery or abnormal anatomy), or pain (e.g. dysesthesia, neuralgia and/or cervicalgia) at the stimulation treatment site.
• Has other significant pain problem (e.g. cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the Investigator may confound the study assessments.
• 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, sphenopalatine ganglion stimulator, or occipital nerve stimulator).
• Has been implanted with metal cervical spine hardware or has a metallic implant near the stimulation treatment site.
• Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for acute treatment of migraine.
• Has initiated new, or changed existing medications for migraine prophylaxis in the previous 2 months.
• Is using marijuana (including medical marijuana) for any indications, more than twice a month.
• Currently takes simple analgesics or non-steroidal anti-inflammatory drugs (NSAIDS) greater than 15 days per month, or triptans, ergots or combined analgesics greater than 10 days per month.
• Currently takes opioids greater than 2 days per month for headache relief or body pain.
• Has undergone nerve block (occipital or other) in the head or neck within the last 2 months, or Botox injections within the last 6 months.

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (10)

University Aldo Moro, Ospedale Pediatrico

Bari, Italy

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria

Bologna, Italy

Location

University Hospital of Careggi

Florence, Italy

Location

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Italy

Location

IRCSS "National Neurological Institute C. Mondino" Foundation

Pavia, Italy

Location

S. Maria della Misericordia Hospital

Perugia, Italy

Location

INM Neuromed IRCCS

Pozzilli, Italy

Location

IRCCS San Raffaele Pisana

Rome, Italy

Location

Sant'Andrea Hospital, Sapienza University of Rome

Rome, Italy

Location

University of Turin

Turin, Italy

Location

Related Publications (3)

• Martelletti P, Barbanti P, Grazzi L, Pierangeli G, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Tassorelli C, Liebler E, de Tommaso M; PRESTO Study Group. Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Nov 1;19(1):101. doi: 10.1186/s10194-018-0929-0.

  PMID: 30382909 DERIVED

• Grazzi L, Tassorelli C, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Oct 19;19(1):98. doi: 10.1186/s10194-018-0928-1.

  PMID: 30340460 DERIVED

• Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.

  PMID: 29907608 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Affairs
• Organization: electroCore INC

clinical@electrocore.com

+1 973 355 6683

Study Officials

• Cristina Tassorelli, MD, PhD

  IRCSS "National Neurological Institute C. Mondino" Foundation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 19, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)