A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.

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. Read our disclaimer for details. Identifier: NCT01958125
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
ElectroCore LLC

Brief Summary:
The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks.

Condition or disease Intervention/treatment Phase
Cluster Headache Device: gammaCore Not Applicable

Detailed Description:
The study is a prospective double blind, randomized, sham-controlled, multi-center investigation designed for comparison of two parallel groups, GammaCore® (active treatment) and a sham, (in-active) treatment. The study period begins with a 1-week run-in period, followed by a 2 week comparative period when the subjects are randomized (1:1) to either active treatment or sham (in-active) treatment. The comparative period will be followed by an open label 2 week period, where the subjects in the sham treatment group will switch in treatment assignment and receive an active treatment and the active group will continue to receive an active treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of GammaCore®, a Non-invasive Neurostimulator Device for the Acute Relief of Episodic and Chronic Cluster Headache.
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: gammacore
gammacore active device to be used noninvasively to the vagal nerve in the neck.
Device: gammaCore
Vagal stimulation
Placebo Comparator: inactive gammacore
same as the active treatment, but without the therapy treatment provided
Device: gammaCore
Vagal stimulation

Primary Outcome Measures :
  1. severity of headache [ Time Frame: 4 weeks ]
    Comparison of the pain free rates at 15 minutes following the treatment

Secondary Outcome Measures :
  1. Reduction of disability [ Time Frame: 4 weeks ]
    Comparison of scores of disability on a 5 step disability scale

  2. Quality of Life [ Time Frame: 4 weeks ]
    Questionnaires answered by the subjects will be compared

  3. Use of rescue medication [ Time Frame: 4 weeks ]
    Comparison of subjects who need to the use of medication for rescue of symptoms

  4. Pain [ Time Frame: 4 weeks ]
    Pain free from symptoms at 30 minutes after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is 18 years or older
  • Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
  • Is capable of completing the 5-point pain scale, disability scale and other self-assessments
  • Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
  • Is able to provide written Informed Consent

Exclusion Criteria:1.

  • Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
  • 2. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
  • 3. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site
  • 4. Is currently taking medication for indications other than CH that in the opinion of the clinician may interfere with the study
  • 5. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
  • 6. Diagnosed or suspected secondary headache
  • 7. Has other significant pain problem that might confound the study assessments in the opinion of the investigator
  • 8. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary artery disease or recent (5 years) myocardial infarction
  • 9. Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction)
  • 10. Has had a previous, cervical vagotomy
  • 11. Has uncontrolled high blood pressure
  • 12. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
  • 13. Has a history of carotid endarterectomy or vascular neck surgery
  • 14. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site
  • 15. Has a recent (12 months) or repeated history of syncope
  • 16. Has a recent (12 months) or repeated history of seizure
  • 17. Has a known history or suspicion of substance abuse or addiction, or overuse of acute headache medication
  • 18. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study
  • 19. Is pregnant, nursing, thinking of becoming pregnant in the next 6 weeks 20. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
  • 21. Is a relative of or an employee of the investigator or the clinical study site

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 identifier (NCT number): NCT01958125

Glostrup Hospital, Danish Headache Centre
Glostrup, Denmark, DK-2600
Westdeutches Kopfschmerzzentrum
Essen, Germany, D-45147
Kopfschmerzklinik Königstein
Königstein im Taunus, Germany, D-61462
Klinikum Grosshadern, University of Munich
Munich, Germany, D-81377
Leiden University Medical Center, Neurology Department, K5-Q-104
Leiden, Netherlands, 2333 ZA
United Kingdom
Hull Royal Infirmary, Neurology Department
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Royal Free, Dept for Neurology and Clinical Neurosciences
London, Greater London, United Kingdom, NW3 2QG
The Southern Hospital, Neurology Department
Glasgow, Lanarkshire, United Kingdom, G51 4TF
The Walton Center, Neurology Department
Liverpool, Merseyside, United Kingdom, L9 7LJ
Sponsors and Collaborators
ElectroCore LLC
Principal Investigator: Peter J. Goadsbury, Prof. Royal Free Hospital, Dept for Neurology and Clinical Neurosciences

Responsible Party: ElectroCore LLC Identifier: NCT01958125     History of Changes
Other Study ID Numbers: GC-003
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2015

Keywords provided by ElectroCore LLC:
vagus nerve stimulation
vagal nerve stimulation
cluster headache
non invasive

Additional relevant MeSH terms:
Cluster Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases