NCT02697292

IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

A Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Autoimmune Epilepsy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2016-03-03
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

1 site across 1 country: United States