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Insufficient enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS Therapy | Experimental | VNS Therapy + Best Medical Practice |
|
| Best Medical Practice | Active Comparator | Best Medical Practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagal Nerve Simulation (VNS) Therapy | Device | VNS Therapy + Best Medical Practice including anti-epileptic drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean change from baseline QOLIE-89 Overall Score at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of Responders at 12 Months |
| Percent of Patients That Are Seizure Free |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillippe Ryvlin, MD | Hopital Neurologique, Lyon, France | Principal Investigator |
| Sophie Leyman, MD | Cyberonics Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie | Brussels | 1070 | Belgium | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11971128 | Background | Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9. | |
| 10660394 | Background | Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | VNS Therapy | VNS Therapy + Best Medical Practice |
| FG001 | Best Medical Practice | Best Medical Practice Without VNS Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Best Medical Practive | Drug | Best Medical Practice including anti-Epileptic Drugs |
|
Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period. |
| 3, 6, 9, 12, 15, 18, 21, 24 months |
| Mean Percent Change in Seizure Frequency | Percent change in total seizuires per week from baseline at 12 months | Mean percent change from baseline in seizure frequency at 12 months |
| Seizure Free Days | Seizure free days is defined as the time from last seizure to study exit date. | From the patient's last seizure to the 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 | 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. | Mean change from baseline CES-D Score at 12 months |
| 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. | Mean change from baseline NDDI-E Score at 12 months |
| 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. | Mean change from baseline CGI-I Score at 12 months |
| 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. | Mean change from baseline AEP Score at 12 months |
| Changes in Anti-epileptic Drugs (AEDs) | Change from baseline in number of AED medications by visit | Change from baseline in number of AEDs at 12 months |
| Retention Rate | Percent of participants who were compliant with the protocol. | At 12 and 24 months |
| Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal | Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal. | At 12 and 24 months |
| 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. | At 12 and 24 months |
| 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. | At 12 and 24 months |
| 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. | At 12 and 24 months |
| 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. | At 12 and 24 months |
| 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 | At 12 and 24 months |
| Percent of Participants Who Were Compliant With the Protocol | Retention rate in patients with less then a 50% reduction in seizures | At 12 and 24 months |
| 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. | Change from baseline up to 12 months |
| 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. | Change from baseline up to 12 months |
| 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. | At 12 and 24 months |
| UZ Gent, Department of Neurology, 1K12/A |
| Ghent |
| 9000 |
| Belgium |
| Foothills Hospital, Neurology Department | Calgary | Alberta | T1Y6J4 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Hopital Notre Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Montreal Neurological Institute, Clinical Research | Montreal | Quebec | H3A 2B4 | Canada |
| CHU Grenoble, Neurology Department | Grenoble | 38043 | France |
| Hopital Roger Salengro, Service de Neurologie | Lille | 59037 | France |
| Hôpital Neurologique, Untité d'épileptologie | Lyon | 69003 | France |
| Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie | Montpellier | 34295 | France |
| Hôpital Sainte-Anne, Service de Neurochirurgie | Paris | 75674 | France |
| Service d'exploration des épilepsies | Strasbourg | 67091 | France |
| CHU Tours, Service de neurologie | Tours | 37044 | France |
| Universitätskliniken Bonn, Klinik für Epileptologie | Bonn | 53105 | Germany |
| Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE | Erlangen | 91054 | Germany |
| Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik | Greifswald | 17487 | Germany |
| Epilepsiezentrum Kork | Kehl-Kork | 77694 | Germany |
| Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum | Marburg | 35039 | Germany |
| Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau | Radeberg | 01465 | Germany |
| Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile | Ancona | 60100 | Italy |
| Universita di Bologna, Clinica Neurologica | Bologna | 40123 | Italy |
| Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience | Florence | 50100 | Italy |
| Ospedale San Paolo, Centro Epilessia | Milan | 20142 | Italy |
| Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica | Monserrato | 09042 | Italy |
| Universita di Pisa, Clinica Neurologica | Pisa | 56126 | Italy |
| Ospedale F. Lotti, NeuroFisioPatalogia | Pontedera | 56025 | Italy |
| Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie | Reggio Calabria | 89100 | Italy |
| Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia | Roma | 00168 | Italy |
| Centro Epilessia, Dipartimento di Neuroscienze | Torino | 10126 | Italy |
| Tergooiziekenhuizen, Dienst Neurologie | Blaricum | 1261, AN | Netherlands |
| Medisch Spectrum Twente, Dienst Neurologie | Enschede | 7513 R | Netherlands |
| Stichting Epilepsie Instituut Nederland, Dienst Neurologie | Heemstede | 8025 BV | Netherlands |
| Kempenhaeghe, Dienst Neurologie | Oosterhout | 4901 ZG | Netherlands |
| Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie | Rotterdam | 3078 HT | Netherlands |
| Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics | Sandvika | 1306 | Norway |
| Hospital Ruber Internacional, Servicio de neurología | Madrid | 28034 | Spain |
| Hospital Clínico de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Clínico Universitario, Servicio de neurología | Valencia | 46010 | Spain |
| Hospital General de Valencia, Neurology/Neurophisiology | Valencia | 46014 | Spain |
| Hospital General Basico De La Defensa de Valencia, Servicio de neurología | Valencia | 46930 | Spain |
| Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation | Gothenburg | 41345 | Sweden |
| Universitetssjukhuset i Lund, Neurologiska kliniken | Lund | 221 85 | Sweden |
| Norrlands Universitetssjukhus, Neurocentrum | Umeå | 901 85 | Sweden |
| Akademiska sjukhuset, Neurocentrum | Uppsala | 751 85 | Sweden |
| Addenbrookes Hospital, Dept of Neurosurgery | Cambridge | CB2 2QQ | United Kingdom |
| Walton Centre, Dept of Neurosciences, Clinical Sciences Centre | Fazakerley | L97LJ | United Kingdom |
| Kings College Hospital, Dept of Neurosurgery | London | SE5 9RS | United Kingdom |
| National Hospital for Neurology and Neurosurgery | London | WC1N3B | United Kingdom |
| 9624191 | Background | Sillanpaa 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. doi: 10.1056/NEJM199806113382402. |
| 3925335 | Background | 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. doi: 10.1056/NEJM198507183130303. |
| 1298221 | Background | 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. doi: 10.1056/NEJM199209103271104. |
| 8710127 | Background | 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. doi: 10.1212/wnl.47.1.68. |
| 12151114 | Background | 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. doi: 10.1016/s0920-1211(02)00065-7. |
| 11114218 | Background | 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. doi: 10.1111/j.1499-1654.2000.001592.x. |
| 10563620 | Background | 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. doi: 10.1212/wnl.53.8.1731. |
| 11552020 | Background | 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. doi: 10.1212/wnl.57.5.879. |
| 12609137 | Background | 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. doi: 10.1006/ebeh.2000.0046. |
| 11074193 | Background | 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. doi: 10.1016/s0920-1211(00)00181-9. |
| 10195186 | Background | 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. doi: 10.1038/4600. |
| 12824707 | Background | 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. doi: 10.1159/000070853. |
| 11673017 | Background | 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. doi: 10.1016/s0920-1211(01)00286-8. |
| 14718691 | Background | 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. doi: 10.1212/wnl.62.1.23. |
| 24754318 | Result | Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E. The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22. |
| Safety Set |
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| Efficacy Set |
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| Baseline and Month 3 |
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| Baseline and Month 6 |
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| Baseline and Month 9 |
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| Baseline and Month 12 |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who completed the baseline assessment and at least one postbaseline follow-up QOLIE-89 assessment, and met local IRB consent requirements
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| ID | Title | Description |
|---|---|---|
| BG000 | VNS Therapy | VNS Therapy + Best Medical Practice |
| BG001 | Best Medical Practice | Best Medical Practice Without VNS Therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Randomization | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Age of Epilepsy Onset | Mean | Standard Deviation | years |
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| Etiology of Epilepsy | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Mean change from baseline QOLIE-89 Overall Score at 12 months |
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| 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. | 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. | Posted | Number | participants | Number of Responders at 12 Months |
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| 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. | 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. | Posted | 3, 6, 9, 12, 15, 18, 21, 24 months |
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| Secondary | Mean Percent Change in Seizure Frequency | Percent change in total seizuires per week from baseline at 12 months | 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. | Posted | Mean | Standard Deviation | Percent Change | Mean percent change from baseline in seizure frequency at 12 months |
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| Secondary | Seizure Free Days | Seizure free days is defined as the time from last seizure to study exit date. | 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. | Posted | From the patient's last seizure to the study exit date |
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| Secondary | Seizure Free Days Over the Last 6 Months | 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. | Posted | Over the last 6 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Mean change from baseline CES-D Score at 12 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Mean change from baseline NDDI-E Score at 12 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a Scale | Mean change from baseline CGI-I Score at 12 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Mean change from baseline AEP Score at 12 months |
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| Secondary | Changes in Anti-epileptic Drugs (AEDs) | Change from baseline in number of AED medications by visit | 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. | Posted | Median | Full Range | Number of AEDs Taken | Change from baseline in number of AEDs at 12 months |
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| Secondary | Retention Rate | Percent of participants who were compliant with the protocol. | 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. | Posted | At 12 and 24 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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| 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 | 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. | Posted | At 12 and 24 months |
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| Secondary | Percent of Participants Who Were Compliant With the Protocol | Retention rate in patients with less then a 50% reduction in seizures | 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. | Posted | At 12 and 24 months |
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| 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. | 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 | Posted | Least Squares Mean | Standard Error | Units on a Scale | Change from baseline up to 12 months |
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| 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. | 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 | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline up to 12 months |
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| 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. | 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. | Posted | At 12 and 24 months |
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24 months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VNS Therapy | VNS Therapy + Best Medical Practice | 5 | 54 | 21 | 54 | ||
| EG001 | Best Medical Practice | Best Medical Practice Without VNS Therapy | 3 | 58 | 10 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Cerebellar Infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
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| Fall | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Suicide Attempt | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Prostate Cancer | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
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| Prostatectomy | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
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| Renal Stone Removal | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
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| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vocal Cord Paralysis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Headache | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
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| Eyelid Disorder | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Complication of Device Insertion | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Facial Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Local Swelling | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
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| Localized Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Fractured Sacrum | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypoesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Mononeuropathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Psychotic Behavior | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Throat Tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Scar Pain | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Vocal Cord Paralysis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Bunker, Senior Director, Global Medical Affairs | Cyberonics, Inc | 281-228-7223 | Mark.Bunker@cyberonics.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
| Male |
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| Unknown |
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