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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by ElectroCore LLC
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01958125
First received: October 4, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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 Intervention
Cluster Headache
Device: gammaCore

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • severity of headache [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Comparison of the pain free rates at 15 minutes following the treatment


Secondary Outcome Measures:
  • Reduction of disability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Comparison of scores of disability on a 5 step disability scale

  • Quality of Life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Questionnaires answered by the subjects will be compared

  • Use of rescue medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Comparison of subjects who need to the use of medication for rescue of symptoms

  • Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Pain free from symptoms at 30 minutes after treatment


Estimated Enrollment: 108
Study Start Date: August 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958125

Contacts
Contact: Annelie Andersson, PM +46 (0)72 1803076 annelie.andersson@electrocoremedical.com

Locations
Denmark
Glostrup Hospital, Danish Headache Centre Recruiting
Glostrup, Denmark, DK-2600
Contact: Rigmor Jensen, Prof.    +45 3863 2062    rigmor.jensen@regionh.dk   
Contact: Malene Danoe, SC    +45 3863 2062    malene.kjaergaard.danoe@regionh.dk   
Principal Investigator: Rigmor Jensen, Prof.         
Sub-Investigator: Louise Lyckhage, MD         
Germany
Westdeutches Kopfschmerzzentrum Not yet recruiting
Essen, Germany, D-45147
Contact: Kasja Rabe, MD    +49 (0)201 4369624    kasja.rabe@uni-due.de   
Contact: Melina Braunstein, SC    +49 (0)201 43696-0    melina.braunstein@uk-essen.de   
Principal Investigator: Kasja Rabe, MD         
Sub-Investigator: Steffen Nägel, MD         
Sub-Investigator: Maja Bak, MD         
Kopfschmerzklinik Königstein Not yet recruiting
Königstein im Taunus, Germany, D-61462
Contact: Charly Gaul, MD    +49 (0)6174 29040    c.gaul@migraene-klinik.de   
Contact: Sabrina Stillger, SC    +49 (0)6174 29040    s.stillger@migraene-klinik.de   
Principal Investigator: Charly Gaul, MD         
Netherlands
Leiden University Medical Center, Neurology Department, K5-Q-104 Not yet recruiting
Leiden, Netherlands, 2333 ZA
Contact: Michel D. Ferrari, Prof.    +31 71 5262895    m.d.ferrari@lumc.nl   
Contact: Ilse de Coo, MD    +31 71 5261645    i.f.de_coo@lumc.nl   
Principal Investigator: Michel D. Ferrari, Prof         
Sub-Investigator: Ilse de Coo, MD         
Sub-Investigator: Gisela M. Terwindt, MD         
Sub-Investigator: Leopoldine A. Wilbrink, MD         
United Kingdom
Hull Royal Infirmary, Neurology Department Recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact: Fayyaz Ahmed, MD    +44 (0)1482 672444    fayyaz.ahmed@hey.nhs.uk   
Contact: Anwar Osman, MD    +44 (0)7870 167407    anwar.osman@hey.nhs.uk   
Principal Investigator: Fayyaz Ahmed, MD         
Sub-Investigator: Anwar Osman, MD         
Royal Free, Dept for Neurology and Clinical Neurosciences Recruiting
London, Greater London, United Kingdom, NW3 2QG
Contact: Peter Goadsby, Prof.    +44 0 20 7794 0500    profgoadsby.research@gmail.com   
Contact: Juana Marin, MD    +44 (0)20 7794 0500    profgoadsby.research@gmail.com   
Principal Investigator: Peter Goadsby, Prof.         
Sub-Investigator: Juana Marin, MD         
Sub-Investigator: Alexander Nesbitt, MD         
The Southern Hospital, Neurology Department Recruiting
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Contact: Alok Tyagi, MD    +44 (0)141 2017542    aloktyagi@nhs.net   
Contact: Anissa Benchiheub, SC    +44 (0)141 2329515    anissa.benchiheub@ggc.scot.nhs.uk   
Principal Investigator: Alok Tyagi, MD         
The Walton Center, Neurology Department Recruiting
Liverpool, Merseyside, United Kingdom, L9 7LJ
Contact: Nicholas Silver, MD    +44 (0)151 5253611    drnicksilver@googlemail.com   
Contact: Kate O'Hanlon, SC    +44(0)151 5295666    kate.o'hanlon@thewaltoncentre.nhs.uk   
Principal Investigator: Nicholas Silver, MD         
Sub-Investigator: Helene Banks, MD         
Sponsors and Collaborators
ElectroCore LLC
Investigators
Principal Investigator: Peter J. Goadsbury, Prof. Royal Free Hospital, Dept for Neurology and Clinical Neurosciences
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01958125     History of Changes
Other Study ID Numbers: GC-003
Study First Received: October 4, 2013
Last Updated: December 2, 2013
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on October 20, 2014