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A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of the gammaCore

This study is currently recruiting participants.
Verified May 2016 by ElectroCore LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02378844
First Posted: March 4, 2015
Last Update Posted: May 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ElectroCore LLC
  Purpose
A prospective, double-blind, randomized, sham-controlled, multicentre investigation.

Condition Intervention
Migraine Device: gammaCore®-R Device: gammaCore®-R Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of the gammaCore®, a Non-invasive Neurostimulator Device, for the Prevention of Episodic Migraine

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Change in the number of migraine days [ Time Frame: last 4 weeks of the randomized/controlled period compared to the subject's own 4-week run-in period. ]

Secondary Outcome Measures:
  • Number of participants with 50% respond rate [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
  • Mean reduction in number of headache days [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
  • Mean reduction in acute headache medications [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
  • Improvement in headache disability using Headache Impact Test-6 [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
  • Usage of acute medication [ Time Frame: up to Week 36 ]
  • Improvement in Migraine Disability Assessment (MIDAS) [ Time Frame: Week 0, 12, 24 and 36 ]
  • Compare changes in Quality of Life EuroQol Questionnaire (EQ-5D-5L) [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period ]
  • Reduction of headache/migraine days in the open label period [ Time Frame: Week 13 to 36 ]
  • Number of participants with Adverse Events [ Time Frame: up to Week 36 ]

Estimated Enrollment: 400
Study Start Date: June 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
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).
Sham Comparator: 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).
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).

Detailed Description:

The study period will begin with a four week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be observation for baseline comparison.

The run-in period will be, followed by a 12 week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment.

The randomized period will be followed by a 24 week open label period, where the subjects in the sham treatment group will switch in treatment assignment and receive a gammaCore®-R and the gammaCore®-R will continue to receive an active treatment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is between the ages of 18 and 75 years.
  2. Has been previously diagnosed with migraine (with or without aura) in accordance with the International Classification of Headache Disorders (ICHD)-3 Beta Classification criteria.
  3. 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.
  4. Has age of onset of migraine less than 50 years old.
  5. Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
  6. 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.).
  7. 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.
  8. Is able to provide written Informed Consent.

Exclusion Criteria:

  1. Has a concomitant medical condition that will require oral or injectable steroids during the study.
  2. Has a history of any intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma.
  3. Has a structural abnormality at the gammaCore®-R treatment site (e.g lymphadenopathy previous surgery or abnormal anatomy).
  4. Has pain at the gammaCore®-R treatment site (e.g.dysesthesia, neuralgia and/or cervicalgia).
  5. 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
  6. Has know or suspected severe cardiac disease(e.g. symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF)).
  7. 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).
  8. 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).
  9. Has had a cervical vagotomy.
  10. Has uncontrolled high blood pressure (systolic >160 diastolic > 100 after 3 repeated measurements within 24 hours).
  11. 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).
  12. Has been implanted with metal cervical spine hardware or has a metallic implant near the gammaCore®-R stimulation site.
  13. Has a known history of suspicion of secondary headache.
  14. Has a history of syncope (within the last five years).
  15. Has a history of seizures (within the last five years).
  16. Has a known or suspicion of substance abuse or addiction (within the last 5 years).
  17. Is using marijuana (including medical marijuana) for any indications, more than twice a month.
  18. 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 for headaches or other body pain.
  19. Currently takes prescription opioids greater than 2 days per month for headaches or body pain.
  20. Has taken medications for migraine prophylaxis in the previous 30 days.
  21. Has previous diagnosis of medication overuse headache (MoH) , which has reverted to episodic migraine within the last 6 months.
  22. Meets the ICHD-3 Beta Classification criteria for chronic migraine (> 15 headache days per month).
  23. Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for the prophylaxis of migraine .
  24. Has had surgery for migraine prevention.
  25. Has undergone nerve block (occipital or other) in the head or neck within the last 2 months.
  26. Has received Botox injections within the last 6 months.
  27. Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use and accepted form of birth control.
  28. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  29. 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).
  30. Is a relative of or an employee of the investigator or the clinical study site.
  31. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study.
  32. Has previously used the gammaCore® device.
  Contacts and Locations
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): NCT02378844


Contacts
Contact: Hans-Christoph Diener, Professor Phone: +49 (0)201 723 2461 hans.diener@uk-essen.de
Contact: Kasja Solbach, MD +49 (0)201 723 2461 kasja.solbach@uk-essen.de

Locations
Belgium
Neurology Department, University of Liège Recruiting
Liège, Belgium, BE-4000
Contact: Delphine Magis, MD    +32 42 307811    dmagis@chu.ulg.ac.be   
Principal Investigator: Delphine Magis, MD         
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, DK-2600
Contact: Messoud Ashina, MD    +45 38 632275    ashina@dadlnet.dk   
Principal Investigator: Messoud Ashina, MD         
Sub-Investigator: Casper Christensen, MD         
Sub-Investigator: Samaira Younis, MD         
Sub-Investigator: Katarina Mondrup, MD         
Sub-Investigator: Anna Luise Vollesen, MD         
Sub-Investigator: Mohammad Al-Mahdi Al-Karagholi, MD         
Germany
Neurologische Klinik und Poliklinik, Charité Campus Mitte Recruiting
Berlin, Germany, D-10117
Contact: Uwe Reuter, MD    +49 304 50560274    uwe.reuter@charite.de   
Sub-Investigator: Heike Israel-Willner, MD         
Sub-Investigator: Lars Neeb, MD         
Principal Investigator: Uwe Reuter, MD         
Klinik für Neurologie, Universitätsklinikum Essen Recruiting
Essen, Germany, D-45147
Contact: Hans-Christoph Diener, Professor    +49 (0)201 723 2460    hans.diener@uk-essen.de   
Contact: Kasja Solbach, MD    +49 (0)201 723 2461    kasja.solbach@uk-essen.de   
Sub-Investigator: Kasja Solbach, MD         
Principal Investigator: Hans-Christoph Diener, Prof.         
Sub-Investigator: Philinie Berger, MD         
CTC, University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, D-20251
Contact: Arne May, Prof.    +49 40 7410 59189    a.may@uke.uni-hamburg.de   
Sub-Investigator: Alen Jambrecina, MD         
Principal Investigator: Arne May, Prof.         
Sub-Investigator: Jan Hoffmann, MD         
Sub-Investigator: Sandra Zivotic, MD         
Migräne- und Kopfschmertzklinik Königstein Recruiting
Königstein, Germany, D-61462
Contact: Charly Gaul, MD    +49 (0)6174 29040    c.gaul@migraine-klinik.de   
Sub-Investigator: Sonja Resch, MD         
Principal Investigator: Charly Gaul, MD         
Klinik für Neurologie, Ludwig-Maximilliams-Universität, Klinikum Grosshadern Recruiting
München, Germany, D-81377
Contact: Andreas Straube, Professor    +49 (0)89 4400 73900    Andreas.Straube@med.uni-muenchen.de   
Sub-Investigator: Ruth Ruscheweyh, MD         
Principal Investigator: Andreas Straube, Prof.         
Sub-Investigator: Katharina Kamm, MD         
Zentrum für Neurologie und Epileptologie, Hertie-Institut für Klinische Hirnforschung Recruiting
Tübingen, Germany, 72076
Contact: Tobias Freilinger, MD    +49 (0)7071 298-2141    tobias.freilinger@uni-tuebingen.de   
Sub-Investigator: Caroline Freilinger, MD         
Principal Investigator: Tobias Freilinger, MD         
DKD HELIOS Klinik Wiesbaden Recruiting
Wiesbaden, Germany, D-65191
Contact: Till Sprenger, Prof.    +49 (0)611 577-430    Till.Sprenger@helios-kliniken.de   
Principal Investigator: Till Sprenger, Prof.         
Sub-Investigator: Susanne Heitmann, MD         
Sub-Investigator: Tatjana Micheilis, MD         
Sub-Investigator: Klara Orban, MD         
Greece
Neurology Department, Athens Naval Hospital Recruiting
Athens, Greece, GR-11521
Contact: Dimos Mitsikostas, MD       dimosmitsikostas@me.com   
Principal Investigator: Dimos Mitsikostas, MD         
Sub-Investigator: Eleni Kasioti, MD         
Sub-Investigator: Efi Mitropoulou, MD         
Netherlands
Neurology Department, Leiden University Center Completed
Leiden, Netherlands, NL-2333 ZA
Norway
Sandvika Nevrosenter AS Recruiting
Sandvika, Norway, N-1300
Contact: Anne Christine Buckley Poole, MD    +47 67 522080    tine@poole.no   
Sub-Investigator: Einar Kinge, MD         
Principal Investigator: Anne Christine Buckley Poole, MD         
Spain
Headache Unit, University Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Contact: Patricia Pozo Rosich, MD    +34 934 89 30    ppozorosich@yahoo.com   
Principal Investigator: Patricia Pozo Rosich, MD         
Servicio de Neurologia, Hospital Ruber Internacional Not yet recruiting
Madrid, Spain, 28034
Contact: Margarita Sanchez del Rio, MD    +34 91 387 52 50    msanchezdelrio@ruberinternacional.es   
Principal Investigator: Margarita Sanchez del Rio, MD         
Servicio de Neurologia, Clinica Universidad de Navarra Recruiting
Pamplona, Spain, ES-31008
Contact: Pablo Irimia, MD    +34 948 255 400    pirimia@unav.es   
Principal Investigator: Pablo Imiria, MD         
Servicio de Neurologia, Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, ES-46010
Contact: Miguel JA Láinez, MD    +34 963 868863    miguel.lainez@sen.es   
Principal Investigator: Miguel JA Láinez, MD         
Sub-Investigator: Ana Suller         
United Kingdom
Basildon University Hospital Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Contact: Farooq Maniyar, MD    +44 (0)1268 524900    farooq.maniyar@btuh.nhs.uk   
Principal Investigator: Farooq Maniyar, MD         
School of Clinical and Expermental Medicine Recruiting
Birmingham, United Kingdom, B15 2TT
Contact: Alexandra Sinclair, MD    +44 (0)121 414 8857    A.B.Sinclair@bham.ac.uk   
Principal Investigator: Alexandra Sinclair, MD         
Sub-Investigator: Ghaniah Hassan-Smith, MD         
Neurology Department, The Southern Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Alok Tyagi, MD    +44 (0)141 232 7541    alok.tyagi@nhs.net   
Sub-Investigator: Georg Gorri, MD         
Principal Investigator: Alok Tyagi, MD         
Sub-Investigator: Johann Selvarajah, MD         
Neurology Department, Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Contact: Fayyaz Ahmed, MD    +44 (0)1482 875875    fayyaz.ahmed@hey.nhs.uk   
Principal Investigator: Fayyaz Ahmed, MD         
Sub-Investigator: Randa Nimeri, MD         
Sub-Investigator: Alina Buture, MD         
Neurology Department, The Walton Center Recruiting
Liverpool, United Kingdom, L9 7LJ
Contact: Nicholas Silver, MD    +44 (0)151 525 3611    nicholas.silver@thewaltoncentre.nhs.uk   
Sub-Investigator: Heike Arndt, MD         
Principal Investigator: Nicholas Silver, MD         
Sub-Investigator: Wojciech Pietkiewicz, MD         
Neurology Department, King's College London Recruiting
London, United Kingdom, SE5 9PJ
Contact: Peter J. Goadsby, Prof.    +44 (0) 20 3299 3106    peter.goadsby@kcl.ac.uk   
Principal Investigator: Peter J. Goadsby, Prof.         
Sub-Investigator: Francesca Puledda, MD         
Sub-Investigator: Nazia Karsan, MD         
Sub-Investigator: Pyari Bose, MD         
Sub-Investigator: Diana Wei, MD         
Sub-Investigator: Amy Tso, MD         
Sponsors and Collaborators
ElectroCore LLC
Investigators
Principal Investigator: Hans-Christoph Diener, Professor Universtätsklinikum Essen
  More Information

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT02378844     History of Changes
Other Study ID Numbers: GM-11
First Submitted: February 18, 2015
First Posted: March 4, 2015
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be presented

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