Trial Outcomes & Findings for IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy (NCT NCT02697292)

NCT ID: NCT02697292

Last Updated: 2019-12-30

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 17 participants
• Primary outcome timeframe: baseline, 5 weeks
• Results posted on: 2019-12-30

Participant Flow

Participant milestones

Measure	Placebo/Normal Saline Group 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.	Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo/Normal Saline Group n=9 Participants 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.	Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group n=8 Participants Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.	Total n=17 Participants Total of all reporting groups
Age, Continuous	70 years n=9 Participants	70 years n=8 Participants	70 years n=17 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	2 Participants n=8 Participants	5 Participants n=17 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	6 Participants n=8 Participants	12 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	8 participants n=8 Participants	17 participants n=17 Participants

PRIMARY outcome

Timeframe: baseline, 5 weeks

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

Outcome measures

Measure	Placebo/Normal Saline Group n=9 Participants 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.	Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group n=8 Participants Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
Change in Seizure Frequency From Baseline to 5 Weeks	2 Participants	6 Participants

SECONDARY outcome

Timeframe: baseline, 5 weeks

Population: One subject did not complete the assessment at week 5 for the placebo arm

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)

Outcome measures

Measure	Placebo/Normal Saline Group n=8 Participants 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.	Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group n=8 Participants Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds.
Change in Cognitive Assessment	5 Participants	8 Participants

Adverse Events

Placebo/Normal Saline Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo/Normal Saline Group n=9 participants at risk 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.	Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group n=8 participants at risk Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds.
Nervous system disorders Encephalitis	11.1% 1/9 • Number of events 1 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.	0.00% 0/8 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.
General disorders Fall	11.1% 1/9 • Number of events 1 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.	12.5% 1/8 • Number of events 1 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.
General disorders Headache	11.1% 1/9 • Number of events 1 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.	0.00% 0/8 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Number of events 1 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.	0.00% 0/8 • The study period during which adverse events were collected is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately 6 weeks.

Additional Information

Sean J. Pittock, M.D.

Mayo Clinic

Phone: 507-2084-4741

Email: Pittock.Sean@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place