NCT01958125

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

October 4, 2013

Results QC Date

February 28, 2018

Last Update Submit

February 25, 2019

Conditions

Cluster Headache

Keywords

vagus nerve stimulationvagal nerve stimulationnVNSVNScluster headachenon invasivegammacore

Outcome Measures

Primary Outcomes (1)

  • Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment

    Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks. Data was collected in the patient diary.

    2 weeks

Secondary Outcomes (4)

  • Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline

    2 weeks

  • Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment

    2 weeks

  • Patients Who Used Any Type of Rescue Medication

    2 weeks

  • Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment

    2 weeks

Study Arms (2)

gammacore

ACTIVE COMPARATOR

gammacore active device to be used noninvasively to the vagal nerve in the neck.

Device: gammaCore

inactive gammacore

PLACEBO COMPARATOR

same as the active treatment, but without the therapy treatment provided

Device: gammaCore

Interventions

gammaCoreDEVICE

Vagal stimulation

gammacoreinactive gammacore

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
  • \. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
  • \. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site
  • \. Is currently taking medication for indications other than CH that in the opinion of the clinician may interfere with the study
  • \. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
  • \. Diagnosed or suspected secondary headache
  • \. Has other significant pain problem that might confound the study assessments in the opinion of the investigator
  • \. 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
  • \. 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)
  • \. Has had a previous, cervical vagotomy
  • \. Has uncontrolled high blood pressure
  • \. 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
  • \. Has a history of carotid endarterectomy or vascular neck surgery
  • \. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site
  • \. Has a recent (12 months) or repeated history of syncope
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Glostrup Hospital, Danish Headache Centre

Glostrup Municipality, DK-2600, Denmark

Location

Westdeutches Kopfschmerzzentrum

Essen, D-45147, Germany

Location

Kopfschmerzklinik Königstein

Königstein im Taunus, D-61462, Germany

Location

Klinikum Grosshadern, University of Munich

Munich, D-81377, Germany

Location

Leiden University Medical Center, Neurology Department, K5-Q-104

Leiden, 2333 ZA, Netherlands

Location

Hull Royal Infirmary, Neurology Department

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Royal Free, Dept for Neurology and Clinical Neurosciences

London, Greater London, NW3 2QG, United Kingdom

Location

The Southern Hospital, Neurology Department

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

The Walton Center, Neurology Department

Liverpool, Merseyside, L9 7LJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31246132DERIVED

Related Links

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Director Clinical Affairs
Organization
electroCore Inc.
clinical@electrocorellc.com
+1 973 355 6683

Study Officials

  • Peter J. Goadsbury, Prof.

    Royal Free Hospital, Dept for Neurology and Clinical Neurosciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2013

First Posted

October 8, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

February 26, 2019

Results First Posted

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

The study is publlished and no other IPD data will be shared.

Locations

GB(4)DK(1)DE(3)NL(1)