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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 122
- 试验地点
- 48
- 主要终点
- Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VNS Therapy
VNS Therapy + Best Medical Practice
干预措施: Vagal Nerve Simulation (VNS) Therapy (Device)
Best Medical Practice
Best Medical Practice
干预措施: Best Medical Practive (Drug)
结局指标
主要结局
Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
时间窗: 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.
次要结局
- Percent of Patients That Are Seizure Free(3, 6, 9, 12, 15, 18, 21, 24 months)
- Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score(Mean change from baseline NDDI-E Score at 12 months)
- Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures(At 12 and 24 months)
- Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score(Mean change from baseline CES-D Score at 12 months)
- Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal(At 12 and 24 months)
- Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures(At 12 and 24 months)
- Response Rate(Number of Responders at 12 Months)
- Mean Percent Change in Seizure Frequency(Mean percent change from baseline in seizure frequency at 12 months)
- Seizure Free Days Over the Last 6 Months(Over the last 6 months)
- 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)
- Seizure Free Days(From the patient's last seizure to the study exit date)
- Change in the Number of Anti-epileptic Drugs Prescribed(At 12 and 24 months)
- 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)
- Change From Baseline in Adverse Event Profile (AEP) Score(Mean change from baseline AEP Score at 12 months)
- Changes in Anti-epileptic Drugs (AEDs)(Change from baseline in number of AEDs at 12 months)
- Retention Rate(At 12 and 24 months)
- Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures(At 12 and 24 months)
- Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures(At 12 and 24 months)
- Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction(At 12 and 24 months)
- Percent of Participants Who Were Compliant With the Protocol(At 12 and 24 months)
- 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)