NCT02697292

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 30, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

February 19, 2016

Results QC Date

December 12, 2019

Last Update Submit

December 12, 2019

Conditions

Autoimmune Epilepsy

Keywords

Intravenous ImmunoglobulinVGKCAutoimmune epilepsyGamumex-C

Outcome Measures

Primary Outcomes (1)

  • Change in Seizure Frequency From Baseline to 5 Weeks

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

    baseline, 5 weeks

Secondary Outcomes (1)

  • Change in Cognitive Assessment

    baseline, 5 weeks

Study Arms (2)

Placebo/Normal Saline Group

PLACEBO COMPARATOR

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.

Drug: Intravenous ImmunoglobulinDrug: PlacebosDrug: Normal Saline

Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group

ACTIVE COMPARATOR

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

Drug: Intravenous ImmunoglobulinDrug: Normal Saline

Interventions

Intravenous ImmunoglobulinDRUG

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.

Also known as: Gamunex-C
Intravenous Immunoglobulin (IVIG) (Gamunex-C) GroupPlacebo/Normal Saline Group
PlacebosDRUG

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.

Also known as: Normal Saline
Placebo/Normal Saline Group
Normal SalineDRUG

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

Intravenous Immunoglobulin (IVIG) (Gamunex-C) GroupPlacebo/Normal Saline Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Immunoglobulins, IntravenousHizentraSaline Solution

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Sean J. Pittock, M.D.
Organization
Mayo Clinic
Pittock.Sean@mayo.edu
507-2084-4741

Study Officials

  • Sean Pittock, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

December 30, 2019

Results First Posted

December 30, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)