A Phase 4 interventional study of IVIG and Prednisolone in Epilepsy, Unspecified, Intractable, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
The purpose of the study is to investigate effect of immunotherapy in intractable cryptogenic epilepsy patients with autoimmune antibody.
Cryptogenic epilepsy is an epilepsy of presumed symptomatic nature but the cause has not been identified. It account for at least 40% of adult-onset epilepsy. Autoimmune encephalitis including classic paraneoplastic syndrome and autoimmune synaptic encephalitis is a new category of immune-mediated disorders which often has favorable outcome. Recent studies reported that immunotherapy improves seizure outcome in medically intractable epilepsy patients with clinical and serological evidence of an autoimmune basis. Neural autoantibodies were detected in 22% of epilepsy due to unknown cause in a study, mostly from the antiepileptic drug(AED)-resistant epilepsy group. Of the patients who received immunotherapy, 75% archived >50% reduction in seizure frequency.
Many patients with cryptogenic epilepsy are refractory to AED and significant percent of cryptogenic epilepsy harbor neural autoantibody. In those cases, immunotherapy is suggestive based on favorable outcome of immunotherapy in autoimmune encephalitis and autoimmune epilepsy. Investigators aim to investigate the response to immunotherapy in intractable cryptogenic epilepsy patients with neural autoantibodies.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous immunoglobulin (IVIG) and oral prednisolone. IVIG and oral prednisolone are administered simultaneously: IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day).
Other: IVIG · Drug: Prednisolone
No immunotherapy.
IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
Percent seizure reduction
Time frame: 3 months
Seizure free rate
Time frame: 3 months
Responder rate
Time frame: 3 months
Treatment failure rate
Time frame: 3 months
Quality of life scores as measured by QOLIE-31
Time frame: 3 months
Quality of life scores as measured by BDI-2
Time frame: 3 months
Cognition scores as measured by K-MMSE
Time frame: 3 months
Amount of epileptiform discharge measured by EEG
Time frame: 3 months
Plan to share: No
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital