Clinical trial · Interventional
IVIG Treatment for Refractory Immune-Related Adult Epilepsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility criteria, unable for Phase 2 of study, \& phase 1 was terminated.
Summary
Brief summary (as posted)
The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG). The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG. At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Diseases, Nervous System | — | UNRESOLVED | — |
| Epilepsy, Cryptogenic | — | UNRESOLVED | — |
| Epilepsy, Partial | — | UNRESOLVED | — |
| Limbic Encephalitis | — | UNRESOLVED | — |
| Seizure Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVIG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- all subjects
- description
- IVIG
- interventionNames
- Drug: IVIG
Primary outcomes (1)
- measure
- Immune Abnormalities
- timeFrame
- Screening visit
- description
- neuronal nuclear, cytoplasmic, and cell surface autoantibodies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months. * Age 18 to 50. * Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy. * Refractory to an adequate trial of two or more main-line anti-epileptic drugs. * Ability to keep a seizure diary. * Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis Exclusion Criteria: * History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects. * Evidence of psychogenic epilepsy. * History of convulsive status epilepticus. * History of primary generalized epilepsy in a first degree relative. * Known serious medical illness.
References
Publications (14)
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- BACKGROUNDGraus F, Keime-Guibert F, Rene R, Benyahia B, Ribalta T, Ascaso C, Escaramis G, Delattre JY. Anti-Hu-associated paraneoplastic encephalomyelitis: analysis of 200 patients. Brain. 2001 Jun;124(Pt 6):1138-48. doi: 10.1093/brain/124.6.1138. PMID 11353730
- BACKGROUNDGultekin SH, Rosenfeld MR, Voltz R, Eichen J, Posner JB, Dalmau J. Paraneoplastic limbic encephalitis: neurological symptoms, immunological findings and tumour association in 50 patients. Brain. 2000 Jul;123 ( Pt 7):1481-94. doi: 10.1093/brain/123.7.1481. PMID 10869059
- BACKGROUNDJacobs DA, Fung KM, Cook NM, Schalepfer WW, Goldberg HI, Stecker MM. Complex partial status epilepticus associated with anti-Hu paraneoplastic syndrome. J Neurol Sci. 2003 Sep 15;213(1-2):77-82. doi: 10.1016/s0022-510x(03)00130-8. PMID 12873758
- BACKGROUNDLawn ND, Westmoreland BF, Kiely MJ, Lennon VA, Vernino S. Clinical, magnetic resonance imaging, and electroencephalographic findings in paraneoplastic limbic encephalitis. Mayo Clin Proc. 2003 Nov;78(11):1363-8. doi: 10.4065/78.11.1363. PMID 14601695
- BACKGROUNDLucchinetti CF, Kimmel DW, Lennon VA. Paraneoplastic and oncologic profiles of patients seropositive for type 1 antineuronal nuclear autoantibodies. Neurology. 1998 Mar;50(3):652-7. doi: 10.1212/wnl.50.3.652. PMID 9521251
- BACKGROUNDMcKeon A, Ahlskog JE, Britton JW, Lennon VA, Pittock SJ. Reversible extralimbic paraneoplastic encephalopathies with large abnormalities on magnetic resonance images. Arch Neurol. 2009 Feb;66(2):268-71. doi: 10.1001/archneurol.2008.556.