IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
NCT ID: NCT02697292
Last Updated: 2019-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
17 participants
INTERVENTIONAL
2016-02-29
2018-12-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Intravenous Immunoglobulin
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.
Placebos
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
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
Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group
Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
Intravenous Immunoglobulin
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
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
Interventions
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Intravenous Immunoglobulin
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.
Placebos
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Grifols Shared Services North America
UNKNOWN
Option Care
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Sean Pittock
Principal Investigator
Principal Investigators
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Sean Pittock, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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15-005649
Identifier Type: -
Identifier Source: org_study_id