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| Name | Class |
|---|---|
| Grifols Shared Services North America, Inc. | INDUSTRY |
| Option Care | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Normal Saline Group | Placebo Comparator | 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 | Active Comparator | Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Immunoglobulin | Drug | GAMUNEX-C is a clear a ready-to-use sterile solution of human immune globulin protein for intravenous administration. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg IVIG for 4 weeks [week 3 and 5] for 2 infusions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seizure Frequency From Baseline to 5 Weeks | The number of subjects who experience a ≥ 50% reduction in seizure frequency | baseline, 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Assessment | 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sean Pittock, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
| PubMed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group | Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Seizure Frequency From Baseline to 5 Weeks | The number of subjects who experience a ≥ 50% reduction in seizure frequency | Posted | Count of Participants | Participants | baseline, 5 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalitis | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean J. Pittock, M.D. | Mayo Clinic | 507-2084-4741 | Pittock.Sean@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2016 | Dec 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| C558471 | Hizentra |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| Placebos | Drug | Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Dose will be determined based on ideal wt. with not to exceed 80 grams. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg for 4 weeks [week 3 and 5] for 2 infusions. |
|
|
| Normal Saline | Drug | Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Subjects will receive 500 ml normal saline before and after the higher dose infusion of 1g/kg |
|
| baseline, 5 weeks |
Subjects who received IVIG for 4 infusions. Subjects maintained their stable dose of antiepileptic meds. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Cognitive Assessment | 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) | One subject did not complete the assessment at week 5 for the placebo arm | Posted | Count of Participants | Participants | baseline, 5 weeks |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group | Subjects who received IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds. | 0 | 8 | 0 | 8 | 1 | 8 |
| Fall | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |