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

Phase 4TerminatedNCT00522418

Cyberonics, Inc.122 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Epilepsy Partial Epilepsy

Interventions

Vagal Nerve Simulation (VNS) TherapyDEVICE

VNS Therapy + Best Medical Practice including anti-epileptic drugs

Best Medical PractiveDRUG

Best Medical Practice including anti-Epileptic Drugs

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (48)

Outcomes

Primary Outcomes

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.

Time frame: Mean change from baseline QOLIE-89 Overall Score at 12 months

Secondary Outcomes

Response Rate

Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.

Time frame: Number of Responders at 12 Months

Percent of Patients That Are Seizure Free

Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.

Time frame: 3, 6, 9, 12, 15, 18, 21, 24 months

Mean Percent Change in Seizure Frequency

Percent change in total seizuires per week from baseline at 12 months

Time frame: Mean percent change from baseline in seizure frequency at 12 months

Seizure Free Days

Seizure free days is defined as the time from last seizure to study exit date.

Time frame: From the patient's last seizure to the study exit date

Seizure Free Days Over the Last 6 Months

Data from ClinicalTrials.gov

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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

...and 38 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Change from baseline in number of AEDs at 12 months

Retention Rate

Percent of participants who were compliant with the protocol.

Time frame: 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.

Time frame: At 12 and 24 months

Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures

Time frame: At 12 and 24 months

Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction

Time frame: At 12 and 24 months

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures

Time frame: At 12 and 24 months

Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: At 12 and 24 months