Clinical trial NCT01958125: A Randomized Multicentre Study for the Acute Relief of Episodic and Chronic Cluster Headache.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache
Keywords: vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
cluster headache
non invasive
gammacore
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline
timeFrame: 2 weeks
measure: Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment
timeFrame: 2 weeks
measure: Patients Who Used Any Type of Rescue Medication
timeFrame: 2 weeks
measure: Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, Danish Headache Centre
city: Essen
country: Germany
facility: Westdeutches Kopfschmerzzentrum
city: Königstein im Taunus
country: Germany
facility: Kopfschmerzklinik Königstein
city: Munich
country: Germany
facility: Klinikum Grosshadern, University of Munich
city: Leiden
country: Netherlands
facility: Leiden University Medical Center, Neurology Department, K5-Q-104
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary, Neurology Department
state: East Yorkshire
city: London
country: United Kingdom
facility: Royal Free, Dept for Neurology and Clinical Neurosciences
state: Greater London
city: Glasgow
country: United Kingdom
facility: The Southern Hospital, Neurology Department
state: Lanarkshire
city: Liverpool
country: United Kingdom
facility: The Walton Center, Neurology Department
state: Merseyside
Study officials:
affiliation: Royal Free Hospital, Dept for Neurology and Clinical Neurosciences
name: Peter J. Goadsbury, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Coo IF, Marin JC, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019 Jul;39(8):967-977. doi: 10.1177/0333102419856607. Epub 2019 Jun 10.