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

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ClinicalTrials.gov Identifier: NCT02378844
Recruitment Status : Active, not recruiting
First Posted : March 4, 2015
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC

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

Condition or disease Intervention/treatment Phase
Migraine Device: gammaCore®-R Device: gammaCore®-R Sham Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 479 participants
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 gammaCore®, a Non-invasive Vagal Nerve Stimulator (nVNS), for Prevention of Episodic Migraine
Actual Study Start Date : June 2015
Actual Primary Completion Date : February 1, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. 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. ]
  3. Reduction in acute headache medications [ Time Frame: The last four weeks in the randomization period compared to the four week run-in period. ]
  4. 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. ]
  5. Improvement in Migraine Disability Assessment (MIDAS) [ Time Frame: Week 0, 12, 24 and 36 ]
  6. 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 ]
  7. Reduction of headache/migraine days in the open label period [ Time Frame: Week 13 to 36 ]
  8. Number of participants with Adverse Events [ Time Frame: up to Week 36 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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


Locations
Belgium
Neurology Department, University of Liège
Liège, Belgium, BE-4000
Denmark
Danish Headache Center
Glostrup, Denmark, DK-2600
Germany
Neurologische Klinik und Poliklinik, Charité Campus Mitte
Berlin, Germany, D-10117
Klinik für Neurologie, Universitätsklinikum Essen
Essen, Germany, D-45147
CTC, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, D-20251
Migräne- und Kopfschmertzklinik Königstein
Königstein, Germany, D-61462
Klinik für Neurologie, Ludwig-Maximilliams-Universität, Klinikum Grosshadern
München, Germany, D-81377
Zentrum für Neurologie und Epileptologie, Hertie-Institut für Klinische Hirnforschung
Tübingen, Germany, 72076
DKD HELIOS Klinik Wiesbaden
Wiesbaden, Germany, D-65191
Greece
Neurology Department, Athens Naval Hospital
Athens, Greece, GR-11521
Netherlands
Neurology Department, Leiden University Center
Leiden, Netherlands, NL-2333 ZA
Norway
Sandvika Nevrosenter AS
Sandvika, Norway, N-1300
Spain
Headache Unit, University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Servicio de Neurologia, Hospital Ruber Internacional
Madrid, Spain, 28034
Servicio de Neurologia, Clinica Universidad de Navarra
Pamplona, Spain, ES-31008
Servicio de Neurologia, Hospital Clinico Universitario de Valencia
Valencia, Spain, ES-46010
United Kingdom
Basildon University Hospital
Basildon, Essex, United Kingdom, SS16 5NL
School of Clinical and Expermental Medicine
Birmingham, United Kingdom, B15 2TT
Neurology Department, The Southern Hospital
Glasgow, United Kingdom, G51 4TF
Neurology Department, Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Neurology Department, The Walton Center
Liverpool, United Kingdom, L9 7LJ
Neurology Department, King's College London
London, United Kingdom, SE5 9PJ
Sponsors and Collaborators
ElectroCore LLC
Investigators
Principal Investigator: Hans-Christoph Diener, Professor Universtätsklinikum Essen

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT02378844     History of Changes
Other Study ID Numbers: GM-11
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be presented

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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