Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522418
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : August 29, 2007
Results First Posted : May 17, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Partial Epilepsy
Interventions Device: Vagal Nerve Simulation (VNS) Therapy
Drug: Best Medical Practive
Enrollment 122
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description VNS Therapy + Best Medical Practice Best Medical Practice Without VNS Therapy
Period Title: Overall Study
Started 59 63
Safety Set 54 [1] 58 [1]
Efficacy Set 48 [2] 48 [3]
Baseline and Month 3 47 [4] 47 [4]
Baseline and Month 6 38 [5] 45 [5]
Baseline and Month 9 33 [6] 35 [6]
Baseline and Month 12 31 [7] 29 [7]
Completed 2 [8] 5 [8]
Not Completed 57 58
Reason Not Completed
Local IRB Consent Violation             5             5
Early Study Termination             46             47
Noncompliance             2             2
Reason Not Specified             3             1
Consent Withdraw             1             2
Lack of Efficacy             0             1
[1]
Data of 5 randomized patients removed due to lack of ICF approval by site’s local ethics committee.
[2]
6 pts. data excluded: exited prior to collection of baseline data & one postbaseline followup QOLIE
[3]
10 pts. data excluded: exited prior to collection of baseline data & one postbaseline followup QOLIE
[4]
Completed Baseline and Month 3
[5]
Completed Baseline and Month 6
[6]
Completed Baseline and Month 9
[7]
Completed Baseline and Month 12
[8]
Completed 2-year follow-up
Arm/Group Title VNS Therapy Best Medical Practice Total
Hide Arm/Group Description VNS Therapy + Best Medical Practice Best Medical Practice Without VNS Therapy Total of all reporting groups
Overall Number of Baseline Participants 48 48 96
Hide Baseline Analysis Population Description
All participants who completed the baseline assessment and at least one postbaseline follow-up QOLIE-89 assessment, and met local IRB consent requirements
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 48 participants 96 participants
38  (13) 41  (11) 40  (12)
[1]
Measure Description: Age at Randomization
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
Female
24
  50.0%
21
  43.8%
45
  46.9%
Male
24
  50.0%
27
  56.3%
51
  53.1%
Age of Epilepsy Onset  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 48 participants 96 participants
13  (14) 16  (14) 15  (14)
Etiology of Epilepsy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
Structural/Metabolic 26 26 52
Unknown 22 22 44
1.Primary Outcome
Title Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.5  (7.2) 1.2  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method F Test
Comments [Not Specified]
2.Secondary Outcome
Title Response Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
10 7
3.Secondary Outcome
Title Percent of Patients That Are Seizure Free
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Mean Percent Change in Seizure Frequency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
-19.1  (43.92) -1.0  (56.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method F-Test
Comments [Not Specified]
5.Secondary Outcome
Title Seizure Free Days
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Seizure Free Days Over the Last 6 Months
Hide Description [Not Specified]
Time Frame Over the last 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-2.2  (7.0) 0.5  (8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method F-Test
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Time Frame Mean change from baseline NDDI-E Score at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-1.0  (2.2) -0.2  (3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method F-Test
Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.8  (0.8) -0.3  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method F-Test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Adverse Event Profile (AEP) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-6.0  (11.4) -3.2  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VNS Therapy, Best Medical Practice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method F-Test
Comments [Not Specified]
11.Secondary Outcome
Title Changes in Anti-epileptic Drugs (AEDs)
Hide Description Change from baseline in number of AED medications by visit
Time Frame Change from baseline in number of AEDs at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 31 28
Median (Full Range)
Unit of Measure: Number of AEDs Taken
0
(-1 to 1)
0
(-1 to 2)
12.Secondary Outcome
Title Retention Rate
Hide Description Percent of participants who were compliant with the protocol.
Time Frame At 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal
Hide Description Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.
Time Frame At 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures
Time Frame At 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change in the Number of Anti-epileptic Drugs Prescribed
Hide Description Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Time Frame At 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Percent of Participants Who Were Compliant With the Protocol
Hide Description Retention rate in patients with less then a 50% reduction in seizures
Time Frame At 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Baseline Adverse Event Profile Score >= 40
Hide Arm/Group Description:
Population with Baseline Adverse Event Profile Score >= 40
Overall Number of Participants Analyzed 61
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
VNS Therapy 3.3  (1.14)
Best Medical Practice 0.7  (1.08)
21.Secondary Outcome
Title Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Baseline Adverse Event Profile Score < 40
Hide Arm/Group Description:
Population with Baseline Adverse Event Profile Score < 40
Overall Number of Participants Analyzed 34
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
VNS Therapy 3.3  (1.50)
Best Medical Practice 0.5  (1.52)
22.Secondary Outcome
Title Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description:
VNS Therapy + Best Medical Practice
Best Medical Practice Without VNS Therapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description A total of 122 patients were randomized to receive VNS + BMP or BMP alone. Data from one study site (including 10 randomized patients) was removed from the analysis datasets due to lack of ICF approval by site's local ethics committee. The remaining 112, VNS + BMP (n=54) & BMP alone (n=58), randomized patients were included in the safety analyses.
 
Arm/Group Title VNS Therapy Best Medical Practice
Hide Arm/Group Description VNS Therapy + Best Medical Practice Best Medical Practice Without VNS Therapy
All-Cause Mortality
VNS Therapy Best Medical Practice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VNS Therapy Best Medical Practice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/54 (9.26%)      3/58 (5.17%)    
General disorders     
Fall  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Suicide Attempt  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Injury, poisoning and procedural complications     
Head Injury  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Disorder  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Neck Pain  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Pain in Extremity  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Nervous system disorders     
Depression  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Cerebellar Infarction  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Convulsion  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Epilepsy  1  1/54 (1.85%)  1 1/58 (1.72%)  1
Paraesthesia  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Vocal Cord Paralysis  1  1/54 (1.85%)  3 0/58 (0.00%)  0
Renal and urinary disorders     
Urinary Tract Infection  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Respiratory, thoracic and mediastinal disorders     
Laryngospasm  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Respiratory Arrest  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Surgical and medical procedures     
Prostate Cancer  1  1/54 (1.85%)  2 0/58 (0.00%)  0
Prostatectomy  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Renal Stone Removal  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VNS Therapy Best Medical Practice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/54 (38.89%)      10/58 (17.24%)    
Cardiac disorders     
Arrhythmia  1  2/54 (3.70%)  2 0/58 (0.00%)  0
Ear and labyrinth disorders     
Ear Pain  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Tinnitus  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Endocrine disorders     
Hypothyroidism  1  0/54 (0.00%)  0 2/58 (3.45%)  2
Eye disorders     
Eyelid Disorder  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Glaucoma  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Vision Blurred  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Gastrointestinal disorders     
Abdominal Pain  1  1/54 (1.85%)  2 0/58 (0.00%)  0
Constipation  1  0/54 (0.00%)  0 1/58 (1.72%)  1
General disorders     
Asthenia  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Chest Pain  1  3/54 (5.56%)  3 0/58 (0.00%)  0
Headache  1  3/54 (5.56%)  3 1/58 (1.72%)  1
Complication of Device Insertion  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Facial Pain  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Local Swelling  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Pyrexia  1  1/54 (1.85%)  1 1/58 (1.72%)  1
Infections and infestations     
Localized Infection  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Sinusitis  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Urinary Tract Infection  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Injury, poisoning and procedural complications     
Fractured Sacrum  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Fall  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Musculoskeletal and connective tissue disorders     
Neck Pain  1  2/54 (3.70%)  2 0/58 (0.00%)  0
Nervous system disorders     
Epilepsy  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Hypoesthesia  1  3/54 (5.56%)  4 0/58 (0.00%)  0
Mononeuropathy  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Sedation  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Tremor  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Convulsion  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Vocal Cord Paralysis  1  1/54 (1.85%)  2 0/58 (0.00%)  0
Psychiatric disorders     
Aggression  1  2/54 (3.70%)  2 0/58 (0.00%)  0
Anxiety  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Depression  1  3/54 (5.56%)  3 0/58 (0.00%)  0
Disorientation  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Insomnia  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Psychotic Behavior  1  1/54 (1.85%)  1 1/58 (1.72%)  1
Renal and urinary disorders     
Nephrolithiasis  1  2/54 (3.70%)  2 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Dysphonia  1  8/54 (14.81%)  9 0/58 (0.00%)  0
Dyspnoea  1  1/54 (1.85%)  2 0/58 (0.00%)  0
Oropharyngeal Pain  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Throat Tightness  1  2/54 (3.70%)  2 0/58 (0.00%)  0
Skin and subcutaneous tissue disorders     
Nail Disorder  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Rash  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Scar Pain  1  1/54 (1.85%)  1 0/58 (0.00%)  0
Vascular disorders     
Hypertension  1  0/54 (0.00%)  0 1/58 (1.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
This study was terminated as a result of a decision by Cyberonics, Inc. The decision to terminate the study was primarily due to insufficient enrollment. The decision was not the result of a safety or efficacy signal.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator and Site agree not to publish or otherwise publicaly disclose clinical data generated in connection with the Study, unless approved in advance in writing by Cyberonics. Investigators and Site agree to provide Cyberonics with a copy of any proposed publication, abstract, or presentation relating to the research conducted under this Agreement at least 30 days prior to submission for publication or presentation.
Results Point of Contact
Name/Title: Mark Bunker, Senior Director, Global Medical Affairs
Organization: Cyberonics, Inc
Phone: 281-228-7223
Other Publications:
Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT00522418     History of Changes
Other Study ID Numbers: E-100
First Submitted: August 27, 2007
First Posted: August 29, 2007
Results First Submitted: April 2, 2010
Results First Posted: May 17, 2010
Last Update Posted: January 26, 2015