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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01958125
First received: October 4, 2013
Last updated: February 18, 2015
Last verified: February 2015
  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


Enrollment: 120
Study Start Date: August 2013
Study Completion Date: January 2015
Primary Completion Date: October 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

Locations
Denmark
Glostrup Hospital, Danish Headache Centre
Glostrup, Denmark, DK-2600
Germany
Westdeutches Kopfschmerzzentrum
Essen, Germany, D-45147
Kopfschmerzklinik Königstein
Königstein im Taunus, Germany, D-61462
Klinikum Grosshadern, University of Munich
Munich, Germany, D-81377
Netherlands
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
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: February 18, 2015
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 May 25, 2015