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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
Titles & IDs
Public title
Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy
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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.
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Secondary ID [1]
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173/2013
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Secondary ID [2]
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E-AU-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Seizure
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency of Seizures
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Assessment method [1]
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The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).
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Timepoint [1]
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16 weeks
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Secondary outcome [1]
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Duration of Seizure
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Assessment method [1]
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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).
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Timepoint [1]
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16 weeks
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Secondary outcome [2]
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Severity of Seizure
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Assessment method [2]
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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).
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Timepoint [2]
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16 weeks
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Secondary outcome [3]
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Type of Adverse Events
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Assessment method [3]
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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.
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Timepoint [3]
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16 weeks
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Secondary outcome [4]
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Number of Seizure Free Days
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Assessment method [4]
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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).
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Timepoint [4]
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16 weeks
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Secondary outcome [5]
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Quality of Life in Epilepsy
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Assessment method [5]
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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).
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Timepoint [5]
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16 weeks
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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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Southern Neurology - Kogarah
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Recruitment hospital [2]
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Strategic Health Evaluators - Sydney
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2067 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ElectroCore INC
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01910129
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Roy Beran, Professor
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The study was prematurely discontinued
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01910129