Suspended

Intravenous Immunoglobulin (IVIG) for Autoimmune Epilepsy Seizure Reduction

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What is being tested

Intravenous Immunoglobulin

+ Normal Saline

+ Placebos

Drug
Who is being recruted

From 18 to 80 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: February 2016
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2016

Actual date on which the first participant was enrolled.

This study focuses on understanding if Intravenous Immunoglobulin (IVIG), a treatment given through the veins, can significantly lower the number of epileptic seizures in individuals with autoimmune epilepsy, a condition where the body's immune system mistakenly attacks healthy cells in the brain. The study is open to potential participants who will be screened at an outpatient neurology clinic. Those who qualify and consent will partake in this trial. The importance of this study lies in its potential to provide a new treatment option for autoimmune epilepsy, which could improve patients' quality of life and address current challenges in managing this condition. Participants are randomly assigned to receive either IVIG or a placebo treatment for a duration of 5 weeks. After this period, they will return to the Mayo Clinic for an evaluation. Those who initially received the placebo will then be given IVIG for the next 5 weeks, followed by another evaluation at the clinic. All participants will receive monthly phone calls for a year after completing the IVIG treatment. The study measures its results by tracking the number of participants who experience a 50% or greater reduction in seizure frequency from the start of the trial to the end of the 5-week treatment period. This helps evaluate the effectiveness of IVIG in managing autoimmune epilepsy.

Official TitleA Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy
NCT02697292
Principal SponsorMayo Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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.

≥ 2 seizures per week (mean of total over 1 week)

Duration of epilepsy <3 years

Male or female between the ages of 18 and 80 years of age

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14 exclusion criteria prevent from participating
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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps
SuspendedOne Study Center