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About
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.
Full description
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) treatment significantly reduces the number of epileptic seizures in cases of autoimmune epilepsy. Potential participants will be screened at an outpatient neurology clinic visit appointment. Interested qualified potential participants will be consented and offered participation in this trial. Once consent has been obtained, and it is determined that the participant meets all inclusion criteria, the participant will be randomized to either IVIG or placebo treatment for the next 5 weeks. Participants will return to Mayo Clinic for an evaluation. Those participants that received the placebo for 5 weeks will be given IVIG in an open label fashion for 5 weeks (week 7-11) then return to Mayo Clinic for evaluation. All participants will receive monthly phone calls after they complete the IVIG treatment for a period of 1 year from the end of IVIG 5 week course.
Enrollment
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Inclusion criteria
Exclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
17 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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