NCT01701245

Brief Summary

Subjects enrolled into this 10 week study will for the first two weeks document the number of cluster headaches and the means of treating (medication) of these attacks. Subjects will then be randomized to into either two groups. The first group is continuing with standard of care and the second group is treatment with the investigational device (GammaCore) for a period of 4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4 week period. It is hypothesized the the treatment group will have a reduction in mean cluster headaches per week by 50% compared to the standard of care group.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
4 countries

10 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

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 25, 2016

Completed
Last Updated

April 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

October 3, 2012

Results QC Date

September 30, 2015

Last Update Submit

March 23, 2016

Conditions

Chronic Cluster Headache

Keywords

vagus nerve stimulationvagal nerve stimulationnVNSVNScluster headachechronicnon invasivegammacore

Outcome Measures

Primary Outcomes (1)

  • A Change in the Frequency of Cluster Headache Attacks Per Week

    The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) - number of CH attacks during run-in.

    4 weeks

Secondary Outcomes (3)

  • Pain Relief of Headache Attacks

    baseline (2 weeks) and random period(last 2 weeks)

  • Adverse Events

    10 weeks

  • EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)

    10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)

Study Arms (2)

Standard of care

NO INTERVENTION

No intervention, standard of care

GammaCore

ACTIVE COMPARATOR

Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.

Device: GammaCore

Interventions

GammaCoreDEVICE

vagal stimulation

GammaCore

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3. Subjects diagnosed with chronic cluster headache for at least 1 year, without remission periods or with remission periods lasting \<1 month, in accordance with the ICHD-II classification criteria (2ndEd):
  • a. At least 5 attacks fulfilling the following criteria: i. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated ii. Headache is accompanied by at least 1 of the following:
  • Ipsilateral conjunctival injection and/or lacrimation
  • Ipsilateral nasal congestion and/or rhinorrhea
  • Ipsilateral eyelid oedema
  • Ipsilateral forehead and facial sweating
  • Ipsilateral miosis and/or ptosis
  • A sense of restlessness or agitation iii. Attacks have a frequency from 1 every other day to 8 per day and are not attributed to another disorder iv. Attacks recur over \> 1 year without remission periods or with remission periods lasting \< 1 month.
  • \. Has minimum mean attack frequency of 4 CH attacks per week. 5. Is able to distinguish CH from other headaches (i.e. tension-type headaches).
  • \. Is capable of completing headache pain self-assessments. 7. Agrees to use the GammaCore® device as intended and follow all of the requirements of the study, including follow-up visit requirements.
  • \. Is willing to keep all concomitant medication stable during the entire study period.
  • \. Women of child-bearing potential must use 2 methods of contraceptive i.e. hormones and condom.

You may not qualify if:

  • Is currently taking CH prophylactic medication for indications other than CH which in the opinion of the clinician may interfere with the study
  • Has had a change in type or dosage of prophylactic headache medications \< 1 month prior to enrollment
  • Has a history of intracranial or carotid aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  • Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site.
  • 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 TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5years).
  • Has had a previous unilateral or bilateral 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 on the right side.
  • Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore® stimulation site.
  • Has a history, the last 12 month, of syncope.
  • Has a history, the last 12 month of seizures.
  • Has a known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
  • Has psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the investigator may interfere with the study
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Department of Neurology CHR

Liège, Liège, B-4000, Belgium

Location

Krankenhaus Lindenbrunn, Department of Neurology

Coppenbrügge, Coppenbrügge, D-31863, Germany

Location

Westdeutsches Kopfschmerzzentrum

Hufelandstr. 26, Hesse, D-45147, Germany

Location

Migräne- und Kopfschmerzklinik Königstein

Königstein im Taunus, Königstein Im Taunus, D-61462, Germany

Location

Department of Neurology, University of Munich

Munich, Munich, D-813 77, Germany

Location

Neurologische Klinik und Poliklinik

Berlin, State of Berlin, D-10117, Germany

Location

Regional Referral Headache Centre Sant' Andrea Hospital

Rome, Rome, IT-00189, Italy

Location

The Southern Hospital, Neurology Department

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Hull Royal Infirmary, Neurology Department

Hull, HU3 2JZ, United Kingdom

Location

The Walton Centre, Neurology Department

Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (1)

  • Morris J, Straube A, Diener HC, Ahmed F, Silver N, Walker S, Liebler E, Gaul C. Cost-effectiveness analysis of non-invasive vagus nerve stimulation for the treatment of chronic cluster headache. J Headache Pain. 2016;17:43. doi: 10.1186/s10194-016-0633-x. Epub 2016 Apr 22.

    PMID: 27102120DERIVED

MeSH Terms

Conditions

Cluster HeadacheBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Results Point of Contact

Title
Annelie Andersson
Organization
electroCore LLC
annelie.andersson@electrocorellc.com
+46 721 803076

Study Officials

  • Charly Gaul, Dr med

    Migräne- und Kopfschmerzklinik Königstein

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

October 1, 2014

Last Updated

April 25, 2016

Results First Posted

April 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Not planned to share individual data

Locations

IT(1)DE(5)BE(1)GB(3)