A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine

NCT02378844 | Completed Results

• 1 other identifier: GM-11
• Study Type: interventional
• Target: 477
• Locations: 8 countries
• Sites: 22

Brief Summary

A prospective, double-blind, randomized, sham-controlled, multicentre investigation.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change in the Number of Migraine Days

  Change in number of migraine days (as reported in subject diary), comparing the 4 week run-in period to the last 4 weeks in the randomized period.

  last 4 weeks of the randomized/controlled period compared to the subject's own 4-week run-in period.

Secondary Outcomes (9)

• Number of Participants With 50% Responder Rate

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

• Mean Change in Number of Headache Days

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

• Change in Number of Acute Medication Days

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

• Change in Headache Disability Using Headache Impact Test-6

  From four week run-in period to last four weeks in the randomization period

• Number of Participants According to Grade on the Migraine Disability Assessment (MIDAS) Before and After Randomized Period

  3 months - end of run-in period to end of randomized period

Study Arms (2)

gammaCore®-R

ACTIVE COMPARATOR

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Device: gammaCore®-R

gammaCore®-R Sham

SHAM COMPARATOR

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Device: gammaCore®-R Sham

Interventions

gammaCore®-R DEVICE

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R

gammaCore®-R Sham DEVICE

Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

gammaCore®-R 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 between the ages of 18 and 75 years.
• Has been previously diagnosed with migraine (with or without aura) in accordance with the International Classification of Headache Disorders (ICHD)-3 Beta Classification criteria.
• Experience between 5 and 12 migraine days per month (over the last 4 months) with at least 2 of the migraines lasting more than 4 hours.
• Has age of onset of migraine less than 50 years old.
• Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
• Agrees to refrain from initiating or changing the type, dosage or frequency of any prophylactic medications for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anti convulsant, beta blockers, etc.).
• Agrees to use the gammaCore®-R 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.
• Is able to provide written Informed Consent.

You may not qualify if:

• Has a concomitant medical condition that will require oral or injectable steroids during the study.
• Has a history of any intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma.
• Has a structural abnormality at the gammaCore®-R treatment site (e.g lymphadenopathy previous surgery or abnormal anatomy).
• Has pain at the gammaCore®-R treatment site (e.g.dysesthesia, neuralgia and/or cervicalgia).
• 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
• Has know or suspected severe cardiac disease(e.g. symptomatic coronary 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 carotid endarterectomy or other vascular neck surgery).
• Has an abnormal baseline Electrocardiogram (ECG) e.g. second and third degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
• 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, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
• Has been implanted with metal cervical spine hardware or has a metallic implant near the gammaCore®-R stimulation site.
• Has a known history of suspicion of secondary headache.
• Has a history of syncope (within the last five years).
• Has a history of seizures (within the last five years).

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (22)

Neurology Department, University of Liège

Liège, BE-4000, Belgium

Location

Danish Headache Center

Glostrup Municipality, DK-2600, Denmark

Location

Neurologische Klinik und Poliklinik, Charité Campus Mitte

Berlin, D-10117, Germany

Location

Klinik für Neurologie, Universitätsklinikum Essen

Essen, D-45147, Germany

Location

CTC, University Medical Center Hamburg-Eppendorf

Hamburg, D-20251, Germany

Location

Migräne- und Kopfschmertzklinik Königstein

Königstein, D-61462, Germany

Location

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

München, D-81377, Germany

Location

Zentrum für Neurologie und Epileptologie, Hertie-Institut für Klinische Hirnforschung

Tübingen, 72076, Germany

Location

DKD HELIOS Klinik Wiesbaden

Wiesbaden, D-65191, Germany

Location

Neurology Department, Athens Naval Hospital

Athens, GR-11521, Greece

Location

Neurology Department, Leiden University Center

Leiden, NL-2333 ZA, Netherlands

Location

Sandvika Nevrosenter AS

Sandvika, N-1300, Norway

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

Basildon University Hospital

Basildon, Essex, SS16 5NL, United Kingdom

Location

School of Clinical and Expermental Medicine

Birmingham, B15 2TT, United Kingdom

Location

Neurology Department, The Southern Hospital

Glasgow, G51 4TF, United Kingdom

Location

Neurology Department, Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Neurology Department, The Walton Center

Liverpool, L9 7LJ, United Kingdom

Location

Neurology Department, King's College London

London, SE5 9PJ, United Kingdom

Location

Related Publications (1)

• Diener HC, Goadsby PJ, Ashina M, Al-Karagholi MA, Sinclair A, Mitsikostas D, Magis D, Pozo-Rosich P, Irimia Sieira P, Lainez MJ, Gaul C, Silver N, Hoffmann J, Marin J, Liebler E, Ferrari MD. Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial. Cephalalgia. 2019 Oct;39(12):1475-1487. doi: 10.1177/0333102419876920. Epub 2019 Sep 15.

  PMID: 31522546 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

• Hans-Christoph Diener, Professor

  Universtätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 4, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: August 29, 2018
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (6); GR (1); BE (1); NO (1); ES (4); DK (1); DE (7)