Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
Sponsor
Cyberonics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00522418
Collaborator
(none)
122
48
2
28.9
2.5
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy
Study Start Date
:
Feb 1, 2006
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VNS Therapy VNS Therapy + Best Medical Practice |
Device: Vagal Nerve Simulation (VNS) Therapy
VNS Therapy + Best Medical Practice including anti-epileptic drugs
|
| Active Comparator: Best Medical Practice Best Medical Practice |
Drug: Best Medical Practive
Best Medical Practice including anti-Epileptic Drugs
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie | Brussels | Belgium | 1070 | |
| 2 | UZ Gent, Department of Neurology, 1K12/A | Gent | Belgium | 9000 | |
| 3 | Foothills Hospital, Neurology Department | Calgary | Alberta | Canada | T1Y6J4 |
| 4 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 5 | Hopital Notre Dame | Montreal | Quebec | Canada | H2L 4M1 |
| 6 | Montreal Neurological Institute, Clinical Research | Montreal | Quebec | Canada | H3A 2B4 |
| 7 | CHU Grenoble, Neurology Department | Grenoble | France | 38043 | |
| 8 | Hopital Roger Salengro, Service de Neurologie | Lille | France | 59037 | |
| 9 | Hôpital Neurologique, Untité d'épileptologie | Lyon | France | 69003 | |
| 10 | Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie | Montpellier | France | 34295 | |
| 11 | Hôpital Sainte-Anne, Service de Neurochirurgie | Paris | France | 75674 | |
| 12 | Service d'exploration des épilepsies | Strasbourg | France | 67091 | |
| 13 | CHU Tours, Service de neurologie | Tours | France | 37044 | |
| 14 | Universitätskliniken Bonn, Klinik für Epileptologie | Bonn | Germany | 53105 | |
| 15 | Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE | Erlangen | Germany | 91054 | |
| 16 | Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik | Greifswald | Germany | 17487 | |
| 17 | Epilepsiezentrum Kork | Kehl-Kork | Germany | 77694 | |
| 18 | Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum | Marburg | Germany | 35039 | |
| 19 | Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau | Radeberg | Germany | 01465 | |
| 20 | Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile | Ancona | Italy | 60100 | |
| 21 | Universita di Bologna, Clinica Neurologica | Bologna | Italy | 40123 | |
| 22 | Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience | Firenze | Italy | 50100 | |
| 23 | Ospedale San Paolo, Centro Epilessia | Milano | Italy | 20142 | |
| 24 | Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica | Monserrato | Italy | 09042 | |
| 25 | Universita di Pisa, Clinica Neurologica | Pisa | Italy | 56126 | |
| 26 | Ospedale F. Lotti, NeuroFisioPatalogia | Pontedera | Italy | 56025 | |
| 27 | Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie | Reggio Calabria | Italy | 89100 | |
| 28 | Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia | Roma | Italy | 00168 | |
| 29 | Centro Epilessia, Dipartimento di Neuroscienze | Torino | Italy | 10126 | |
| 30 | Tergooiziekenhuizen, Dienst Neurologie | Blaricum | Netherlands | 1261, AN | |
| 31 | Medisch Spectrum Twente, Dienst Neurologie | Enschede | Netherlands | 7513 R | |
| 32 | Stichting Epilepsie Instituut Nederland, Dienst Neurologie | Heemstede | Netherlands | 8025 BV | |
| 33 | Kempenhaeghe, Dienst Neurologie | Oosterhout | Netherlands | 4901 ZG | |
| 34 | Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie | Rotterdam | Netherlands | 3078 HT | |
| 35 | Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics | Sandvika | Norway | 1306 | |
| 36 | Hospital Ruber Internacional, Servicio de neurología | Madrid | Spain | 28034 | |
| 37 | Hospital Clínico de Santiago | Santiago de Compostela | Spain | 15706 | |
| 38 | Hospital Clínico Universitario, Servicio de neurología | Valencia | Spain | 46010 | |
| 39 | Hospital General de Valencia, Neurology/Neurophisiology | Valencia | Spain | 46014 | |
| 40 | Hospital General Basico De La Defensa de Valencia, Servicio de neurología | Valencia | Spain | 46930 | |
| 41 | Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation | Goteborg | Sweden | 41345 | |
| 42 | Universitetssjukhuset i Lund, Neurologiska kliniken | Lund | Sweden | 221 85 | |
| 43 | Norrlands Universitetssjukhus, Neurocentrum | Umea | Sweden | 901 85 | |
| 44 | Akademiska sjukhuset, Neurocentrum | Uppsala | Sweden | 751 85 | |
| 45 | Addenbrookes Hospital, Dept of Neurosurgery | Cambridge | United Kingdom | CB2 2QQ | |
| 46 | Walton Centre, Dept of Neurosciences, Clinical Sciences Centre | Fazakerley | United Kingdom | L97LJ | |
| 47 | Kings College Hospital, Dept of Neurosurgery | London | United Kingdom | SE5 9RS | |
| 48 | National Hospital for Neurology and Neurosurgery | London | United Kingdom | WC1N3B |
Sponsors and Collaborators
- Cyberonics, Inc.
Investigators
- Principal Investigator: Phillippe Ryvlin, MD, Hopital Neurologique, Lyon, France
- Study Director: Sophie Leyman, MD, Cyberonics Europe
Study Documents (Full-Text)
None provided.More Information
Publications
- Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8.
- Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. Review.
- Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10.
- Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. Review.
- Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7.
- Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99.
- Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9.
- Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6.
- Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84.
- Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51.
- Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71.
- Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76.
- McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9.
- Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. Erratum in: Neurology 2000 Apr 25;54(8):1712.
- Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. Review.
- Sillanpää M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22.
Responsible Party:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT00522418
Other Study ID Numbers:
- E-100
First Posted:
Aug 29, 2007
Last Update Posted:
Jan 26, 2015
Last Verified:
Oct 1, 2012
Keywords provided by Cyberonics, Inc.
Additional relevant MeSH terms:
Study Results
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 Detail | 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Period Title: Overall Study | ||
| STARTED | 59 | 63 |
| Safety Set | 54 | 58 |
| Efficacy Set | 48 | 48 |
| Baseline and Month 3 | 47 | 47 |
| Baseline and Month 6 | 38 | 45 |
| Baseline and Month 9 | 33 | 35 |
| Baseline and Month 12 | 31 | 29 |
| COMPLETED | 2 | 5 |
| NOT COMPLETED | 57 | 58 |
Baseline Characteristics
| Arm/Group Title | VNS Therapy | Best Medical Practice | Total |
|---|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy | Total of all reporting groups |
| Overall Participants | 48 | 48 | 96 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
38
(13)
|
41
(11)
|
40
(12)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
50%
|
21
43.8%
|
45
46.9%
|
| Male |
24
50%
|
27
56.3%
|
51
53.1%
|
| Age of Epilepsy Onset (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
13
(14)
|
16
(14)
|
15
(14)
|
| Etiology of Epilepsy (participants) [Number] | |||
| Structural/Metabolic |
26
54.2%
|
26
54.2%
|
52
54.2%
|
| Unknown |
22
45.8%
|
22
45.8%
|
44
45.8%
|
Outcome Measures
| Title | Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [units on a scale] |
5.5
(7.2)
|
1.2
(6.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .01 |
| Comments | ||
| Method | F Test | |
| Comments | ||
| Title | Response Rate |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Number [participants] |
10
20.8%
|
7
14.6%
|
| Title | Percent of Patients That Are Seizure Free |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Mean Percent Change in Seizure Frequency |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [Percent Change] |
-19.1
(43.92)
|
-1.0
(56.66)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | F-Test | |
| Comments | ||
| Title | Seizure Free Days |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Seizure Free Days Over the Last 6 Months |
|---|---|
| Description | |
| Time Frame | Over the last 6 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [Units on a Scale] |
-2.2
(7.0)
|
0.5
(8.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | F-Test | |
| Comments | ||
| Title | Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [Units on a Scale] |
-1.0
(2.2)
|
-0.2
(3.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | F-Test | |
| Comments | ||
| Title | Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [Units on a Scale] |
-0.8
(0.8)
|
-0.3
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | F-Test | |
| Comments | ||
| Title | Change From Baseline in Adverse Event Profile (AEP) Score |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 29 |
| Mean (Standard Deviation) [Units on a scale] |
-6.0
(11.4)
|
-3.2
(6.9)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VNS Therapy, Best Medical Practice |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | F-Test | |
| Comments | ||
| Title | Changes in Anti-epileptic Drugs (AEDs) |
|---|---|
| Description | Change from baseline in number of AED medications by visit |
| Time Frame | Change from baseline in number of AEDs at 12 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 31 | 28 |
| Median (Full Range) [Number of AEDs Taken] |
0
|
0
|
| Title | Retention Rate |
|---|---|
| Description | Percent of participants who were compliant with the protocol. |
| Time Frame | At 12 and 24 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal |
|---|---|
| Description | Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal. |
| Time Frame | At 12 and 24 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures |
|---|---|
| Description | 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Change in the Number of Anti-epileptic Drugs Prescribed |
|---|---|
| Description | Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures |
| Time Frame | At 12 and 24 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Percent of Participants Who Were Compliant With the Protocol |
|---|---|
| Description | Retention rate in patients with less then a 50% reduction in seizures |
| Time Frame | At 12 and 24 months |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
| Title | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Population with Baseline Adverse Event Profile Score >= 40 |
| Measure Participants | 61 |
| VNS Therapy |
3.3
(1.14)
|
| Best Medical Practice |
0.7
(1.08)
|
| Title | Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Population with Baseline Adverse Event Profile Score < 40 |
| Measure Participants | 34 |
| VNS Therapy |
3.3
(1.50)
|
| Best Medical Practice |
0.5
(1.52)
|
| Title | Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | VNS Therapy + Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Measure Participants | 0 | 0 |
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| VNS Therapy | Best Medical Practice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/54 (9.3%) | 3/58 (5.2%) | ||
| General disorders | ||||
| Fall | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Suicide Attempt | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Head Injury | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral Disc Disorder | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Neck Pain | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Pain in Extremity | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Nervous system disorders | ||||
| Depression | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Cerebellar Infarction | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Convulsion | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Epilepsy | 1/54 (1.9%) | 1 | 1/58 (1.7%) | 1 |
| Paraesthesia | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Vocal Cord Paralysis | 1/54 (1.9%) | 3 | 0/58 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary Tract Infection | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Laryngospasm | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Respiratory Arrest | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Surgical and medical procedures | ||||
| Prostate Cancer | 1/54 (1.9%) | 2 | 0/58 (0%) | 0 |
| Prostatectomy | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Renal Stone Removal | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| VNS Therapy | Best Medical Practice | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/54 (38.9%) | 10/58 (17.2%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 2/54 (3.7%) | 2 | 0/58 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Ear Pain | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Tinnitus | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Endocrine disorders | ||||
| Hypothyroidism | 0/54 (0%) | 0 | 2/58 (3.4%) | 2 |
| Eye disorders | ||||
| Eyelid Disorder | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Glaucoma | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Vision Blurred | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal Pain | 1/54 (1.9%) | 2 | 0/58 (0%) | 0 |
| Constipation | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| General disorders | ||||
| Asthenia | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Chest Pain | 3/54 (5.6%) | 3 | 0/58 (0%) | 0 |
| Headache | 3/54 (5.6%) | 3 | 1/58 (1.7%) | 1 |
| Complication of Device Insertion | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Facial Pain | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Local Swelling | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Pyrexia | 1/54 (1.9%) | 1 | 1/58 (1.7%) | 1 |
| Infections and infestations | ||||
| Localized Infection | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Sinusitis | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Urinary Tract Infection | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fractured Sacrum | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Fall | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Metabolism and nutrition disorders | ||||
| Hypercholesterolaemia | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Neck Pain | 2/54 (3.7%) | 2 | 0/58 (0%) | 0 |
| Nervous system disorders | ||||
| Epilepsy | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Hypoesthesia | 3/54 (5.6%) | 4 | 0/58 (0%) | 0 |
| Mononeuropathy | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Sedation | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Tremor | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Convulsion | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Vocal Cord Paralysis | 1/54 (1.9%) | 2 | 0/58 (0%) | 0 |
| Psychiatric disorders | ||||
| Aggression | 2/54 (3.7%) | 2 | 0/58 (0%) | 0 |
| Anxiety | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Depression | 3/54 (5.6%) | 3 | 0/58 (0%) | 0 |
| Disorientation | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Insomnia | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Psychotic Behavior | 1/54 (1.9%) | 1 | 1/58 (1.7%) | 1 |
| Renal and urinary disorders | ||||
| Nephrolithiasis | 2/54 (3.7%) | 2 | 0/58 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Dysphonia | 8/54 (14.8%) | 9 | 0/58 (0%) | 0 |
| Dyspnoea | 1/54 (1.9%) | 2 | 0/58 (0%) | 0 |
| Oropharyngeal Pain | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Throat Tightness | 2/54 (3.7%) | 2 | 0/58 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Nail Disorder | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Rash | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
| Scar Pain | 1/54 (1.9%) | 1 | 0/58 (0%) | 0 |
| Vascular disorders | ||||
| Hypertension | 0/54 (0%) | 0 | 1/58 (1.7%) | 1 |
Limitations/Caveats
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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| Mark.Bunker@cyberonics.com |
Responsible Party:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT00522418
Other Study ID Numbers:
- E-100
First Posted:
Aug 29, 2007
Last Update Posted:
Jan 26, 2015
Last Verified:
Oct 1, 2012