Epilepsy, Partial Epilepsy
Conditions
Keywords
Epilepsy, VNS Therapy
Brief summary
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.
Detailed description
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.
Interventions
VNS Therapy + Best Medical Practice including anti-epileptic drugs
DRUGBest Medical Practive
Best Medical Practice including anti-Epileptic Drugs
Sponsors
Cyberonics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient has confirmed partial onset seizures. * Seizure activity is not adequately controlled by patient's current AED regimen. * Patient is between 16 and 75 years of age. * Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance. * Patient has previously failed at least 3 AEDs in single or combination use. * During baseline evaluation period, patient should take at least 1 AED. * Patient should have confirmed epilepsy for a minimum of 2 years. * Patient's AED regimen is stable for at least 1 month prior to enrolment. * Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment. * Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.
Exclusion criteria
* Patient has pseudoseizures or a history of pseudoseizures. * Patient has idiopathic generalised epilepsy or unclassified epilepsy. * Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy. * Patient has had a unilateral or bilateral cervical vagotomy. * Patient has a history of non-compliance with the completion of a seizure diary. * Patient has taken an investigational drug within a period of 3 months prior to inclusion. * Patient is currently using another investigational medical device. * Patient has a significant cardiac or pulmonary condition currently under treatment. * Patient has previously undergone brain surgery. * Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator. * Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment | Mean change from baseline QOLIE-89 Overall Score at 12 months | QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Number of Responders at 12 Months | Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period. |
| Percent of Patients That Are Seizure Free | 3, 6, 9, 12, 15, 18, 21, 24 months | Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period. |
| Mean Percent Change in Seizure Frequency | Mean percent change from baseline in seizure frequency at 12 months | Percent change in total seizuires per week from baseline at 12 months |
| Seizure Free Days | From the patient's last seizure to the study exit date | Seizure free days is defined as the time from last seizure to study exit date. |
| Seizure Free Days Over the Last 6 Months | Over the last 6 months | — |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score | Mean change from baseline CES-D Score at 12 months | The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms. |
| Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score | Mean change from baseline NDDI-E Score at 12 months | The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms. |
| Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months | Mean change from baseline CGI-I Score at 12 months | The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
| Change From Baseline in Adverse Event Profile (AEP) Score | Mean change from baseline AEP Score at 12 months | Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. |
| Changes in Anti-epileptic Drugs (AEDs) | Change from baseline in number of AEDs at 12 months | Change from baseline in number of AED medications by visit |
| Retention Rate | At 12 and 24 months | Percent of participants who were compliant with the protocol. |
| Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures | At 12 and 24 months | QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. |
| Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction | At 12 and 24 months | The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms. |
| Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures | At 12 and 24 months | The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms. |
| Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures | At 12 and 24 months | Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. |
| Change in the Number of Anti-epileptic Drugs Prescribed | At 12 and 24 months | Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures |
| Percent of Participants Who Were Compliant With the Protocol | At 12 and 24 months | Retention rate in patients with less then a 50% reduction in seizures |
| Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40 | Change from baseline up to 12 months | QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. |
| Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40 | Change from baseline up to 12 months | QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events. |
| Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures | At 12 and 24 months | The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
| Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal | At 12 and 24 months | Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal. |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. There were 9 screen failures out of 131 screened patients, leaving 122 patients who started the study and are described in the Participant Flow.
Pre-assignment details
Patients were randomized in a 1:1 ratio to the Best Medical Practice With Adjunctive VNS Therapy study group or to the Best Medical Practice Without VNS Therapy study group. VNS Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
Participants by arm
| Arm | Count |
|---|---|
| VNS Therapy VNS Therapy + Best Medical Practice | 48 |
| Best Medical Practice Best Medical Practice Without VNS Therapy | 48 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent Withdraw | 1 | 2 |
| Overall Study | Early Study Termination | 46 | 47 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Local IRB Consent Violation | 5 | 5 |
| Overall Study | Noncompliance | 2 | 2 |
| Overall Study | Reason Not Specified | 3 | 1 |
Baseline characteristics
| Characteristic | VNS Therapy | Best Medical Practice | Total |
|---|---|---|---|
| Age, Continuous | 38 Years STANDARD_DEVIATION 13 | 41 Years STANDARD_DEVIATION 11 | 40 Years STANDARD_DEVIATION 12 |
| Age of Epilepsy Onset | 13 years STANDARD_DEVIATION 14 | 16 years STANDARD_DEVIATION 14 | 15 years STANDARD_DEVIATION 14 |
| Etiology of Epilepsy Structural/Metabolic | 26 participants | 26 participants | 52 participants |
| Etiology of Epilepsy Unknown | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 54 | 10 / 58 |
| serious Total, serious adverse events | 5 / 54 | 3 / 58 |
Outcome results
Primary
Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Time frame: Mean change from baseline QOLIE-89 Overall Score at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment | 5.5 units on a scale | Standard Deviation 7.2 |
| Best Medical Practice | Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment | 1.2 units on a scale | Standard Deviation 6.9 |
p-value: 0.01F Test
Secondary
Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures
Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction
The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Change From Baseline in Adverse Event Profile (AEP) Score
Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Time frame: Mean change from baseline AEP Score at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Change From Baseline in Adverse Event Profile (AEP) Score | -6.0 Units on a scale | Standard Deviation 11.4 |
| Best Medical Practice | Change From Baseline in Adverse Event Profile (AEP) Score | -3.2 Units on a scale | Standard Deviation 6.9 |
p-value: 0.26F-Test
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score
The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.
Time frame: Mean change from baseline CES-D Score at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score | -2.2 Units on a Scale | Standard Deviation 7 |
| Best Medical Practice | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score | 0.5 Units on a Scale | Standard Deviation 8.1 |
p-value: 0.17F-Test
Secondary
Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.
Time frame: Mean change from baseline NDDI-E Score at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score | -1.0 Units on a Scale | Standard Deviation 2.2 |
| Best Medical Practice | Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score | -0.2 Units on a Scale | Standard Deviation 3.4 |
p-value: 0.28F-Test
Secondary
Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40
QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Time frame: Change from baseline up to 12 months
Population: This outcome measure includes patients from both arms VNS + BMP (N=17) and BMP alone (N=17), with an overall QOLIE-89 at baseline and any other baseline visit up to 12 months. Subgroup Analysis of Population With Baseline Adverse Event Profile Score \< 40
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VNS Therapy | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40 | VNS Therapy | 3.3 units on a scale | Standard Error 1.5 |
| VNS Therapy | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40 | Best Medical Practice | 0.5 units on a scale | Standard Error 1.52 |
Secondary
Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40
QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.
Time frame: Change from baseline up to 12 months
Population: This outcome measure includes patients from both arms, VNS + BMP (N=30) and BMP alone (N=31), with an overall QOLIE-89 at baseline and any other post baseline visit up to 12 months. Subgroup Analysis of population with Baseline Adverse Event Profile Score \>= 40
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| VNS Therapy | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40 | VNS Therapy | 3.3 Units on a Scale | Standard Error 1.14 |
| VNS Therapy | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40 | Best Medical Practice | 0.7 Units on a Scale | Standard Error 1.08 |
Secondary
Change in the Number of Anti-epileptic Drugs Prescribed
Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Changes in Anti-epileptic Drugs (AEDs)
Change from baseline in number of AED medications by visit
Time frame: Change from baseline in number of AEDs at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for fifty-nine (59) patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VNS Therapy | Changes in Anti-epileptic Drugs (AEDs) | 0 Number of AEDs Taken |
| Best Medical Practice | Changes in Anti-epileptic Drugs (AEDs) | 0 Number of AEDs Taken |
Secondary
Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures
The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months
The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: Mean change from baseline CGI-I Score at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months | -0.8 Units on a Scale | Standard Deviation 0.8 |
| Best Medical Practice | Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months | -0.3 Units on a Scale | Standard Deviation 1.1 |
p-value: 0.03F-Test
Secondary
Mean Percent Change in Seizure Frequency
Percent change in total seizuires per week from baseline at 12 months
Time frame: Mean percent change from baseline in seizure frequency at 12 months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VNS Therapy | Mean Percent Change in Seizure Frequency | -19.1 Percent Change | Standard Deviation 43.92 |
| Best Medical Practice | Mean Percent Change in Seizure Frequency | -1.0 Percent Change | Standard Deviation 56.66 |
p-value: 0.17F-Test
Secondary
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Percent of Participants Who Were Compliant With the Protocol
Retention rate in patients with less then a 50% reduction in seizures
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Percent of Patients That Are Seizure Free
Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures
QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Response Rate
Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.
Time frame: Number of Responders at 12 Months
Population: Due to early study termination \& only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VNS Therapy | Response Rate | 10 participants |
| Best Medical Practice | Response Rate | 7 participants |
Secondary
Retention Rate
Percent of participants who were compliant with the protocol.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Seizure Free Days
Seizure free days is defined as the time from last seizure to study exit date.
Time frame: From the patient's last seizure to the study exit date
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Seizure Free Days Over the Last 6 Months
Time frame: Over the last 6 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.
Secondary
Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal
Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.
Time frame: At 12 and 24 months
Population: This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.