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IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

NCT02697292 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-12-30

Study results available
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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.

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

Sponsors & Collaborators

  • Grifols Shared Services North America

    collaborator UNKNOWN

  • Option Care

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Sean Pittock, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-12-03
Completion
2018-12-03

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697292 on ClinicalTrials.gov