IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
Condition: Autoimmune Epilepsy
MeSH terms: Epilepsy
Intervention: Intravenous Immunoglobulin; Placebos; Normal Saline
Intervention description: GAMUNEX-C is a clear a ready-to-use sterile solution of human immune globulin protein for intravenous administration. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg IVIG for 4 weeks [week 3 and 5] for 2 infusions.; Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Dose will be determined based on ideal wt. with not to exceed 80 grams. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg for 4 weeks [week 3 and 5] for 2 infusions.; Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Subjects will receive 500 ml normal saline before and after the higher dose infusion of 1g/kg
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Intravenous Immunoglobulin; VGKC; Autoimmune epilepsy; Gamumex-C

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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