Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
NCT ID: NCT00522418
Last Updated: 2015-01-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
122 participants
INTERVENTIONAL
2006-02-28
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VNS Therapy
VNS Therapy + Best Medical Practice
Vagal Nerve Simulation (VNS) Therapy
VNS Therapy + Best Medical Practice including anti-epileptic drugs
Best Medical Practice
Best Medical Practice
Best Medical Practive
Best Medical Practice including anti-Epileptic Drugs
Interventions
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Vagal Nerve Simulation (VNS) Therapy
VNS Therapy + Best Medical Practice including anti-epileptic drugs
Best Medical Practive
Best Medical Practice including anti-Epileptic Drugs
Eligibility Criteria
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Inclusion Criteria
* 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 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.
16 Years
ALL
Yes
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phillippe Ryvlin, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Neurologique, Lyon, France
Sophie Leyman, MD
Role: STUDY_DIRECTOR
Cyberonics Europe
Locations
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ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie
Brussels, , Belgium
UZ Gent, Department of Neurology, 1K12/A
Ghent, , Belgium
Foothills Hospital, Neurology Department
Calgary, Alberta, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Hopital Notre Dame
Montreal, Quebec, Canada
Montreal Neurological Institute, Clinical Research
Montreal, Quebec, Canada
CHU Grenoble, Neurology Department
Grenoble, , France
Hopital Roger Salengro, Service de Neurologie
Lille, , France
Hôpital Neurologique, Untité d'épileptologie
Lyon, , France
Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie
Montpellier, , France
Hôpital Sainte-Anne, Service de Neurochirurgie
Paris, , France
Service d'exploration des épilepsies
Strasbourg, , France
CHU Tours, Service de neurologie
Tours, , France
Universitätskliniken Bonn, Klinik für Epileptologie
Bonn, , Germany
Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE
Erlangen, , Germany
Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik
Greifswald, , Germany
Epilepsiezentrum Kork
Kehl-Kork, , Germany
Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum
Marburg, , Germany
Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau
Radeberg, , Germany
Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile
Ancona, , Italy
Universita di Bologna, Clinica Neurologica
Bologna, , Italy
Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience
Florence, , Italy
Ospedale San Paolo, Centro Epilessia
Milan, , Italy
Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica
Monserrato, , Italy
Universita di Pisa, Clinica Neurologica
Pisa, , Italy
Ospedale F. Lotti, NeuroFisioPatalogia
Pontedera, , Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie
Reggio Calabria, , Italy
Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia
Roma, , Italy
Centro Epilessia, Dipartimento di Neuroscienze
Torino, , Italy
Tergooiziekenhuizen, Dienst Neurologie
Blaricum, , Netherlands
Medisch Spectrum Twente, Dienst Neurologie
Enschede, , Netherlands
Stichting Epilepsie Instituut Nederland, Dienst Neurologie
Heemstede, , Netherlands
Kempenhaeghe, Dienst Neurologie
Oosterhout, , Netherlands
Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie
Rotterdam, , Netherlands
Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics
Sandvika, , Norway
Hospital Ruber Internacional, Servicio de neurología
Madrid, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Hospital Clínico Universitario, Servicio de neurología
Valencia, , Spain
Hospital General de Valencia, Neurology/Neurophisiology
Valencia, , Spain
Hospital General Basico De La Defensa de Valencia, Servicio de neurología
Valencia, , Spain
Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation
Gothenburg, , Sweden
Universitetssjukhuset i Lund, Neurologiska kliniken
Lund, , Sweden
Norrlands Universitetssjukhus, Neurocentrum
Umeå, , Sweden
Akademiska sjukhuset, Neurocentrum
Uppsala, , Sweden
Addenbrookes Hospital, Dept of Neurosurgery
Cambridge, , United Kingdom
Walton Centre, Dept of Neurosciences, Clinical Sciences Centre
Fazakerley, , United Kingdom
Kings College Hospital, Dept of Neurosurgery
London, , United Kingdom
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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References
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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.
Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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E-100
Identifier Type: -
Identifier Source: org_study_id
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