IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

PHASE3TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

December 3, 2018

Study Completion Date

December 3, 2018

Conditions
Autoimmune Epilepsy
Interventions
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

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Grifols Shared Services North America

UNKNOWN

collaborator

Option Care

INDUSTRY

lead

Mayo Clinic

OTHER