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| ID | Type | Description | Link |
|---|---|---|---|
| 173/2013 | Other Identifier | clinical trail notification |
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Slow enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gammaCore | Active Comparator | Active stimulation treatment |
|
| sham gammaCore | Placebo Comparator | Inactive stimulation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gammaCore | Device | vagal verve stimulation 3 times a day 8 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
| Severity of Seizure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Roy Beran, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Neurology | Kogarah | New South Wales | 2217 | Australia | ||
| Strategic Health Evaluators |
The study was prematurely discontinued
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| ID | Title | Description |
|---|---|---|
| FG000 | gammaCore Then Sham gammaCore | 8 weeks active stimulation with the gammaCore device , no wash out , followed by 8 weeks sham treatment with the sham device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart |
| FG001 | Sham gammaCore Then gammaCore | 8 weeks sham treatment with the sham device, no wash -out, followed by 8 weeks sham treatment with the with the gammaCore device gammaCore/sham treatment: vagal verve stimulation 3 times a day 8 hours apart |
| FG002 | Run-in Period | Not randomized or allocated to treatment group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Period Phase 1 |
| |||||||||||||
| Randomized Phase 2 |
| |||||||||||||
| Randomized Phase 3 |
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | gammaCore Then Sham gammaCore | 8 weeks Active gammaCore stimulation treatment followed by 8 weeks sham (inactive) gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart |
| BG001 | Sham gammaCore Then gammaCore |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | safety population 3 subjects were missing data in phase 3 (2 from phase 2 active group and 1 from the phase 2 sham group) | Posted | Mean | Full Range | seizures | 16 weeks |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Phase 1 | Not randomized or allocated to treatment group | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased seizure frequency | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | electroCore Inc. | +1 973 355 6683 | clinical@electrocorellc.com |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
| 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. | 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). | 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). | 16 weeks |
| Sydney |
| New South Wales |
| 2067 |
| Australia |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
8 weeks sham (inactive) gammaCore treatment followed by 8 weeks active gammaCore treatment gammaCore: vagal verve stimulation 3 times a day 8 hours apart |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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). | Safety population. One subject has missing data in the active gammacore group. 2 subjects were missing data in phase 3 (1 from phase 2 active group and 1 from the phase 2 sham group) 1 subject in the phase 3 sham group reported 0 seizures during this phase | Posted | Mean | Standard Deviation | minutes | 16 weeks |
|
|
|
| Secondary | 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). | Safety population. 4 subjects were missing data (one in the gammacore group and 3 in the sham group) 3 subjects in the gammacore group were missing data in phase 3 | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | 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. | Safety population. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | 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). | Safety population. 1 subject was missing data in the gammacore group. 1 subject from phase 2 gammacore group and 1 subject from the phase 2 sham group were missing data in phase 3 | Posted | Number | days | 16 weeks |
|
|
|
| Secondary | 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). | Safety population. 2 subject in the gammacore group and 1 subject in the sham group were missing data. 1 subject in the gammacore group was missing data in phase 3 | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
| EG001 | gammaCore Phase 2 | 8 weeks gammaCore stimulation treatment gammaCore vagal verve stimulation 3 times a day 8 hours apart | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | Sham Phase 2 | 8 weeks sham stimulation treatment sham stimulation 3 times a day 8 hours apart | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | gammaCore Phase 3 | 8 weeks gammaCore stimulation treatment gammaCore vagal verve stimulation 3 times a day 8 hours apart | 0 | 5 | 0 | 5 | 2 | 5 |
| EG004 | Sham Phase 3 | 8 weeks sham stimulation treatment sham stimulation 3 times a day 8 hours apart | 0 | 5 | 0 | 5 | 4 | 5 |
| Pain in left leg | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in left shoulder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pains in left ear | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Pain in stomach | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Period pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Right hand pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain left anterior chest wall | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Broken sleep | General disorders | MedDRA | Non-systematic Assessment |
|
| Drowsy | General disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Unusual feeling in nose | General disorders | MedDRA | Non-systematic Assessment |
|
| Unusual feeling in the mouth | General disorders | MedDRA | Non-systematic Assessment |
|
| Nose tingle right side | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Sore throat | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Neck fatigue | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash in left ear | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Feeling of withdrawal from medication | General disorders | MedDRA | Non-systematic Assessment |
|
| Tired eyes | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Change of appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Prominent veins | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Epiphora | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Red spot/bite on both legs | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Feeling of indigestion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Feel bloated | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Difficulty concentrating | General disorders | MedDRA | Non-systematic Assessment |
|
| Pinched nerve (back) | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Left forearm injury | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Right ankle pinched nerve | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Low blood pressure | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Light headed, dizzy, slight nausea, double vision | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Shoulder ache arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tremor in both hands | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Scab on neck | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| tennis elbow returned | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Damaged sciatic nerve | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Right eustachian tube blockage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Flu | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cold | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Loss of balance | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Impaired hearing right ear | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Bland taste | General disorders | MedDRA | Non-systematic Assessment |
|
| Discomfort at site of stimulation | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Paresthesia on top and bottom lip on right side during treatment | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Paresthesia at site of stimulation | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Feeling funny - face and arms | General disorders | MedDRA | Non-systematic Assessment |
|
| Metal taste in mouth during treatment | General disorders | MedDRA | Non-systematic Assessment |
|
| Paresthesia in neck and underarms | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Parethesia teeth | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| vagus nerve stimulation feels abrasive | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tooth fillings irritation | General disorders | MedDRA | Non-systematic Assessment |
|
| Muscle twitching at site of stimulation | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle pain at site of stimulation | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash on neck | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Dull pain on right side of neck going up to right side of head | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| Duration of Seizure Phase 3 |
|
|
| Severity of Seizure Phase 3 |
|
|
| Adverse Events |
|
| Serious Adverse Events |
|
| Phase 2 Number of observed seizure free days |
|
|
| Phase 3 Number of observed days (total) |
|
|
| Phase 3 Number of observed seizure free days |
|
|
| Phase 2 Question 31 |
|
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| Phase 3 Questions 1-30 |
|
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| Phase 3 Question 31 |
|
|