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

NACompletedINTERVENTIONAL
Enrollment

477

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

February 1, 2018

Study Completion Date

August 29, 2018

Conditions
Migraine
Interventions
DEVICE

gammaCore®-R

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

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).

Trial Locations (22)

28034

Servicio de Neurologia, Hospital Ruber Internacional, Madrid

72076

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

BE-4000

Neurology Department, University of Liège, Liège

DK-2600

Danish Headache Center, Glostrup Municipality

D-10117

Neurologische Klinik und Poliklinik, Charité Campus Mitte, Berlin

D-45147

Klinik für Neurologie, Universitätsklinikum Essen, Essen

D-20251

CTC, University Medical Center Hamburg-Eppendorf, Hamburg

D-61462

Migräne- und Kopfschmertzklinik Königstein, Königstein

D-81377

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

D-65191

DKD HELIOS Klinik Wiesbaden, Wiesbaden

GR-11521

Neurology Department, Athens Naval Hospital, Athens

NL-2333 ZA

Neurology Department, Leiden University Center, Leiden

N-1300

Sandvika Nevrosenter AS, Sandvika

08035

Headache Unit, University Hospital Vall d'Hebron, Barcelona

ES-31008

Servicio de Neurologia, Clinica Universidad de Navarra, Pamplona

ES-46010

Servicio de Neurologia, Hospital Clinico Universitario de Valencia, Valencia

SS16 5NL

Basildon University Hospital, Basildon

B15 2TT

School of Clinical and Expermental Medicine, Birmingham

G51 4TF

Neurology Department, The Southern Hospital, Glasgow

HU3 2JZ

Neurology Department, Hull Royal Infirmary, Hull

L9 7LJ

Neurology Department, The Walton Center, Liverpool

SE5 9PJ

Neurology Department, King's College London, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ElectroCore INC

INDUSTRY