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IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

Primary Purpose

Autoimmune Epilepsy

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Intravenous Immunoglobulin

Placebos

Normal Saline

About this trial

This is an interventional treatment trial for Autoimmune Epilepsy focused on measuring Intravenous Immunoglobulin, VGKC, Autoimmune epilepsy, Gamumex-C

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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:

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)
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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo/Normal Saline Group

Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Seizure Frequency From Baseline to 5 Weeks

The number of subjects who experience a ≥ 50% reduction in seizure frequency

Secondary Outcome Measures

Change in Cognitive Assessment

Number of subjects who experienced stable or improved cognitive assessment. Cognitive status was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS is a individually administered standardized battery of 12 tests that measure cognitive decline or improvement taking approximately 30 minutes. Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score (range 40-160)

Full Information

NCT ID

NCT02697292

First Posted

February 19, 2016

Last Updated

December 12, 2019

Sponsor

Mayo Clinic

Collaborators

Grifols Shared Services North America, Option Care

1. Study Identification

Unique Protocol Identification Number

NCT02697292

Brief Title

IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 3, 2018 (Actual)

Study Completion Date

December 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Grifols Shared Services North America, Option Care

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Epilepsy

Keywords

Intravenous Immunoglobulin, VGKC, Autoimmune epilepsy, Gamumex-C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo/Normal Saline Group

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intravenous Immunoglobulin

Other Intervention Name(s)

Gamunex-C

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Normal Saline

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Seizure Frequency From Baseline to 5 Weeks

Description

The number of subjects who experience a ≥ 50% reduction in seizure frequency

Time Frame

baseline, 5 weeks

Secondary Outcome Measure Information:

Title

Change in Cognitive Assessment

Description

Time Frame

baseline, 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Pittock, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials.

Description

Mayo Clinic Clinical Trials

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=Randomized+Placebo+Controlled+Trial+of+IVIG+in+autoimmune+LGI1%2FCASPR2+epilepsy

Description

PubMed

Learn more about this trial

IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy

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