Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy

NCT01910129 | Terminated Results

• 2 other identifiers: E-AU-01173/2013
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.

Conditions

Seizure

Keywords

vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; epilepsy; non invasive; gammacore

Outcome Measures

Primary Outcomes (1)

• Frequency of Seizures

  The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

  16 weeks

Secondary Outcomes (5)

• Duration of Seizure

  16 weeks

• Severity of Seizure

  16 weeks

• Type of Adverse Events

  16 weeks

• Number of Seizure Free Days

  16 weeks

• Quality of Life in Epilepsy

  16 weeks

Study Arms (2)

gammaCore

ACTIVE COMPARATOR

Active stimulation treatment

Device: gammaCore

sham gammaCore

PLACEBO COMPARATOR

Inactive stimulation treatment

Device: gammaCore

Interventions

gammaCore DEVICE

vagal verve stimulation 3 times a day 8 hours apart

gammaCore; sham gammaCore

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is diagnosed with epilepsy with; primary generalized tonic-clonic or partial complex or simple complex or focal onset seizures, with or without secondary generalization.
• The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable
• The patient is receiving a stable dose of up to 2 oral AED medication(s) and is not expected to have any change in his/her baseline AED treatment during the treatment period.
• The patient is having more than 2 recordable seizures a month.

You may not qualify if:

• The patient has had status epilepticus within the last six months.
• The patient has had epilepsy surgery or a VNS implant.
• The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted).
• The patient has had 4 weeks continuous seizure freedom last 2 months.
• The patient has psychogenic non-epileptic seizures (PNES) seizures.
• The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy.
• The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study.
• The patient has had an episode of status epilepticus within 4 weeks of Screening.
• \. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
• \. 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.
• \. 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 bilateral, right, or left cervical vagotomy. 14. Has uncontrolled high blood pressure. 15. 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 recent or repeated history of syncope. 19. Has a known history or suspicion of substance abuse or addiction. 20. In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.

Sponsors & Collaborators

• ElectroCore INC: lead

Study Sites (2)

Southern Neurology

Kogarah, New South Wales, 2217, Australia

Location

Strategic Health Evaluators

Sydney, New South Wales, 2067, Australia

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Clinical Affairs
• Organization: electroCore Inc.

clinical@electrocorellc.com

+1 973 355 6683

Study Officials

• Roy Beran, Professor

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 29, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)