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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01910129




Registration number
NCT01910129
Ethics application status
Date submitted
15/07/2013
Date registered
29/07/2013
Date last updated
23/04/2019

Titles & IDs
Public title
Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
Scientific 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.
Secondary ID [1] 0 0
173/2013
Secondary ID [2] 0 0
E-AU-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seizure 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - gammaCore

Active comparator: gammaCore - Active stimulation treatment

Placebo comparator: sham gammaCore - Inactive stimulation treatment


Treatment: Devices: gammaCore
vagal verve stimulation 3 times a day 8 hours apart
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Seizures
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Duration of Seizure
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Severity of Seizure
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Type of Adverse Events
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Number of Seizure Free Days
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Quality of Life in Epilepsy
Timepoint [5] 0 0
16 weeks

Eligibility
Key inclusion criteria
1. 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.
2. The patient's present antiepileptic drug (AED) therapy is ineffective or intolerable
3. 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.
4. The patient is having more than 2 recordable seizures a month.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has had status epilepticus within the last six months.
2. The patient has had epilepsy surgery or a VNS implant.
3. The patient has had a history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted).
4. The patient has had 4 weeks continuous seizure freedom last 2 months.
5. The patient has psychogenic non-epileptic seizures (PNES) seizures.
6. The patient has a concomitant progressive CNS disease including progressive myoclonus epilepsy.
7. 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.
8. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Southern Neurology - Kogarah
Recruitment hospital [2] 0 0
Strategic Health Evaluators - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2067 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ElectroCore INC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01910129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roy Beran, Professor
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01910129