A Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Seizure Frequency From Baseline to 5 Weeks
研究概览
简要总结
The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces significantly the number of epileptic seizures in cases of autoimmune epileptic seizures.
详细描述
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) treatment significantly reduces the number of epileptic seizures in cases of autoimmune epilepsy. Potential participants will be screened at an outpatient neurology clinic visit appointment. Interested qualified potential participants will be consented and offered participation in this trial. Once consent has been obtained, and it is determined that the participant meets all inclusion criteria, the participant will be randomized to either IVIG or placebo treatment for the next 5 weeks. Participants will return to Mayo Clinic for an evaluation. Those participants that received the placebo for 5 weeks will be given IVIG in an open label fashion for 5 weeks (week 7-11) then return to Mayo Clinic for evaluation. All participants will receive monthly phone calls after they complete the IVIG treatment for a period of 1 year from the end of IVIG 5 week course.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seropositivity for Voltage Gated Potassium Channel Complex (VGKC) complex antibodies or positive for Leucine-Rich, Glioma Inactivated 1 (LGI1)/contactin-associated protein-like 2 (CASPR2) Antibody by cell based assay.
- •And ≥ 2 seizures per week (mean of total over 1 week)
- •And duration of epilepsy <3 years
- •Male or female between the ages of 18 and 80 years of age
- •Women and men of child bearing potential must agree to use a reliable form of contraception throughout the course of the study.
- •Homecare treatment agency available at place of residence.
排除标准
- •History of thrombotic episodes within the 2 years prior to enrollment
- •Known allergic or other severe reactions to blood products including intolerability to previous IVIG
- •Immunoglobulin A (IgA) deficiency
- •Prior failed trial of high dose steroid (prednisone >60mg daily or methylprednisolone >1g weekly for >2 weeks)
- •Reproductive status:
- •Women who are pregnant,
- •Women who are breastfeeding,
- •Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator. (Women of non-childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for > 12 months prior to screen visit.)
- •Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
- •Evidence of serious uncontrolled concomitant diseases that may preclude patient participation (physician determined), as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
- •Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
- •Evidence of chronic active hepatitis B or C.
- •Active ischemic heart disease in the past year prior to baseline.
- •Patients should not have severe renal or hepatic disease (determined by treating physician).
- •Severe hypertension
研究组 & 干预措施
Placebo/Normal Saline Group
Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
干预措施: Intravenous Immunoglobulin (Drug)
Placebo/Normal Saline Group
Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
干预措施: Placebos (Drug)
Placebo/Normal Saline Group
Subjects will receive placebo for 4 infusions. After completion of the blinded phase, subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
干预措施: Normal Saline (Drug)
Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group
Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
干预措施: Intravenous Immunoglobulin (Drug)
Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group
Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Seizure Frequency From Baseline to 5 Weeks
时间窗: baseline, 5 weeks
The number of subjects who experience a ≥ 50% reduction in seizure frequency
次要结局
- Change in Cognitive Assessment(baseline, 5 weeks)