Trial Outcomes & Findings for IVIG Treatment for Refractory Immune-Related Adult Epilepsy (NCT NCT01545518)

Results Overview

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Screening visit

Results posted on

2014-09-01

Participant Flow

Patients enrolled in a medical setting if eligible. Inclusion and exclusion criteria. A total of 20 patients with unexplained refractory epilepsy were screened and tested with a multiple panel for anti-neuronal antibodies.

In comparisons with our original futility criteria, it was apparent that the absence of more powerful findings, and the time it took to collect the ones we have, indicated the virtual impossibility of identifying enough patients with strong autoimmune findings to carry out Phase 2 of this study.

Participant milestones

Participant milestones
Measure	All Subjects IVIG IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=20 Participants IVIG IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Screening visit

Population: No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Charles M. Epstein

Emory University

Phone: 404-778-3633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place