SeizureNCT01910129

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

A study testing gammaCore in people with Seizure, run by ElectroCore INC at 2 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Seizure
What is being tested?: gammaCore
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 2 sitesAustralia
Study dates: Jul 2013to Oct 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.
10. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
11. 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.
12. 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).
13. 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.
16. Has a history of carotid endarterectomy or vascular neck surgery on the right side.
17. Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
18. 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.
21. Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Southern Neurology
Kogarah, New South Wales, 2217
Strategic Health Evaluators
Sydney, New South Wales, 2067

Other trials in Australia

About this study

Official title: A Randomized, Multi-center, Double-blind, Parallel, Crossover Study of a Non-invasive Neurostimulation to the Vagus Nerve With the gammaCore Device for the Reduction in Frequency of Seizures Associated With Epilepsy.

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.

Read the detailed description

The purpose of the study is to determine the effects of non-invasive vagus nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older. Subjects will record 4 weeks of baseline seizure activity before being randomized for a period of 8 weeks to receive and active treatment to an active-sham treatment. All subjects will then receive another 8 weeks of active treatment.

Conditions: Seizure
Being tested: gammaCore
Keywords: vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, epilepsy, non invasive, gammacore
Medical subject headings: Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gammaCoreDevice
vagal verve stimulation 3 times a day 8 hours apart

Study groups in NCT01910129
Study group	Role	What they receive
gammaCore	Active comparator	Active stimulation treatment Receives: Device: gammaCore
sham gammaCore	Placebo comparator	Inactive stimulation treatment Receives: Device: gammaCore

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 16 weeks

Secondary outcomes (5)

Duration of Seizure
Duration of seizure was recorded by the subject in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Measured: 16 weeks
Severity of Seizure
The Seizure Severity Questionnaire (SSQ) is a self-reported assessment tool, which categorizes seizures into three phases: warning, ictal activity and postictal recovery. The recovery phase is subdivided into three components (cognitive, emotional and physical aspects of recovery), each of which is rated for frequency, severity and bothersome. Overall assessment of seizure severity is measured with the last two items.
Items are positively scored from a scale of 1-7, with lower scores representing a better status. 1 = none, never or mild and 7 = extremely frequent, severe or high.
The severity was reported for seizures occuring throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Measured: 16 weeks
Type of Adverse Events
Type of adverse events were split in to Adverse Events, Adverse Device Effects and Serious Adverse Events. Adverse events were reported throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
For frequency see the Adverse Event Table.
Measured: 16 weeks
Number of Seizure Free Days
The number of seizure-free days was collected from the subjects' diary. The total number of days observed days for each phase and the total number of seizure free days for each phase are presented for the course of the study throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
Measured: 16 weeks
Quality of Life in Epilepsy
The Quality of Life in Epilepsy-31 (QOLIE-31) instrument is a self- administered questionnaire. It includes seven subscales: Overall Quality of Life, Seizure Worry, Emotional Well-Being, Energy/Fatigue, Cognitive, Medication Effects, and Social Function. Questions 1-30 can yield seven individual scores (per subtest) and a total (composite) score. Higher scores indicate better QOL with values ranging from 1 to 100.
Question 31 is a subjective assessment of one's general health condition.Higher scores indicate a better-reported general health condition with the range being 1-10.
Scores are presented at end of Intervention 1/Phase 2 (8 weeks) and at the end of Intervention 2/Phase 3 (8 weeks).
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Oct 2014

First posted29 Jul 2013 (estimated)
Study startJul 2013
Primary completionJul 2014
Study completionOct 2014

Why it stopped: Slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SeizureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910129
Sponsor's protocol ID: E-AU-01
Other IDs: 173/2013
Status last verified: Apr 2019
First submitted: 15 Jul 2013
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: The study was prematurely discontinued

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure

All Seizure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Double-blind, Parallel, Crossover Study of a Non-invasive Neurostimulation to the Vagus Nerve With the gammaCore Device for the Reduction in Frequency of Seizures Associated With Epilepsy.
ClinicalTrials.gov ID: NCT01910129
Acronym / sponsor ID: E-AU-01
Conditions: Seizure
Keywords: vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, epilepsy, non invasive, gammacore
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 13 participants (actual)
Lead sponsor: ElectroCore INCIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jul 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Posted 23 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
gammaCore	Active comparator	Device: gammaCoreActive stimulation treatment
sham gammaCore	Placebo comparator	Device: gammaCoreInactive stimulation treatment

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
gammaCorevagal verve stimulation 3 times a day 8 hours apart	Device	gammaCore, sham gammaCore

Primary outcome

Frequency of Seizures
Time frame: 16 weeks
The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).

5 secondary outcomes

Duration of Seizure
Time frame: 16 weeks
Severity of Seizure
Time frame: 16 weeks
Type of Adverse Events
Time frame: 16 weeks
Number of Seizure Free Days
Time frame: 16 weeks
Quality of Life in Epilepsy
Time frame: 16 weeks

Results and safety

Results posted to the registry on 23 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
gammaCore Then Sham gammaCore	0	0
Sham gammaCore Then gammaCore	0	0
Run-in Period	13	13

Primary outcome: Frequency of Seizures

Time frame: 16 weeks. Mean (Full Range). Unit: seizures

Measure	gammaCore Then Sham gammaCore n = 7	Sham gammaCore the gammaCore n = 6
Frequency of Seizure Phase 2	9.1 (2 to 17)	8.2 (2 to 21)
Frequency of Seizure Phase 3	9.4 (2 to 17)	6.6 (0 to 12)

Population analysed: safety population 3 subjects were missing data in phase 3 (2 from phase 2 active group and 1 from the phase 2 sham group)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-in Phase 1	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
gammaCore Phase 2	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Sham Phase 2	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
gammaCore Phase 3	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Sham Phase 3	0 of 5 (0%)	4 of 5 (80%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The study was prematurely discontinued

Related trials for Seizure

RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roy Beran, Professor principal investigator

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing gammaCore in people with Seizure, run by ElectroCore INC at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Seizures (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.