A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of gammaCore®, a Non-invasive Vagal Nerve Stimulator (nVNS), for Prevention of Episodic Migraine

ElectroCore INC22 sites in 8 countries477 target enrollmentJune 2015

ConditionsMigraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Migraine
Sponsor: ElectroCore INC
Enrollment: 477
Locations: 22
Primary Endpoint: Change in the Number of Migraine Days
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, double-blind, randomized, sham-controlled, multicentre investigation.

Detailed Description

The study period will begin with a four week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be observation for baseline comparison. The run-in period will be, followed by a 12 week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment. The randomized period will be followed by a 24 week open label period, where the subjects in the sham treatment group will switch in treatment assignment and receive a gammaCore®-R and the gammaCore®-R will continue to receive an active treatment.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

August 29, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ElectroCore INC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is between the ages of 18 and 75 years.
•Has been previously diagnosed with migraine (with or without aura) in accordance with the International Classification of Headache Disorders (ICHD)-3 Beta Classification criteria.
•Experience between 5 and 12 migraine days per month (over the last 4 months) with at least 2 of the migraines lasting more than 4 hours.
•Has age of onset of migraine less than 50 years old.
•Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
•Agrees to refrain from initiating or changing the type, dosage or frequency of any prophylactic medications for indications other than migraine that in the opinion of the clinician may interfere with the study objectives (e.g. antidepressant, anti convulsant, beta blockers, etc.).
•Agrees to use the gammaCore®-R device as intended, follow all of the requirements of the study including follow-up visit requirements, record required study data in the subject dairy, and other self-assessment questionnaires.
•Is able to provide written Informed Consent.

Exclusion Criteria

•Has a concomitant medical condition that will require oral or injectable steroids during the study.
•Has a history of any intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma.
•Has a structural abnormality at the gammaCore®-R treatment site (e.g lymphadenopathy previous surgery or abnormal anatomy).
•Has pain at the gammaCore®-R treatment site (e.g.dysesthesia, neuralgia and/or cervicalgia).
•Has other significant pain problem (e.g.cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the investigator may confound the study assessments
•Has know or suspected severe cardiac disease(e.g. symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF)).
•Has known or suspected severe cerebrovascular disease, (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery).
•Has an abnormal baseline Electrocardiogram (ECG) e.g. second and third degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
•Has had a cervical vagotomy.
•Has uncontrolled high blood pressure (systolic \>160 diastolic \> 100 after 3 repeated measurements within 24 hours).

Outcomes

Primary Outcomes

Change in the Number of Migraine Days

Time Frame: last 4 weeks of the randomized/controlled period compared to the subject's own 4-week run-in period.

Change in number of migraine days (as reported in subject diary), comparing the 4 week run-in period to the last 4 weeks in the randomized period.

Secondary Outcomes

Number of Participants With 50% Responder Rate(The last four weeks in the randomization period compared to the four week run-in period.)
Number of Participants With Adverse Events(up to Week 36)
Change in Headache Disability Using Headache Impact Test-6(From four week run-in period to last four weeks in the randomization period)
Mean Change in Number of Headache Days(The last four weeks in the randomization period compared to the four week run-in period.)
Change in Number of Acute Medication Days(The last four weeks in the randomization period compared to the four week run-in period.)
Compare Changes in Quality of Life EuroQol Questionnaire 5 Dimensions and 5 Levels (EQ-5D-5L)(From four week run-in period to last four weeks in the randomization period)
Change in Headache Days in the Open Label Period(The 6 month open-label period compared to the four week run-in period)
Number of Participants According to Grade on the Migraine Disability Assessment (MIDAS) Before and After Randomized Period(3 months - end of run-in period to end of randomized period)
Change in Migraine Days in the Open Label Period (Adjusted ANCOVA)(The 6 month open-label period compared to the four week run-in period)