Autoimmune EpilepsyPhase 3NCT02697292
IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
A Phase 3 study testing Intravenous Immunoglobulin and Normal Saline in people with Autoimmune Epilepsy, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Epilepsy
- What is being tested?
- Intravenous Immunoglobulin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 3 Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seropositivity for Voltage Gated Potassium Channel Complex (VGKC) complex antibodies or positive for Leucine-Rich, Glioma Inactivated 1 (LGI1)/contactin-associated protein-like 2 (CASPR2) Antibody by cell based assay.
- And ≥ 2 seizures per week (mean of total over 1 week)
- And duration of epilepsy <3 years
- Male or female between the ages of 18 and 80 years of age
- Women and men of child bearing potential must agree to use a reliable form of contraception throughout the course of the study.
- Homecare treatment agency available at place of residence.
Who cannot join
- 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:
- Women who are pregnant,
Show all 15Show fewer
- Women who are breastfeeding,
- Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator. (Women of non-childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for > 12 months prior to screen visit.)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy
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.
Read the detailed 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.
- Conditions
- Autoimmune Epilepsy
- Being tested
- Intravenous Immunoglobulin, Placebos, Normal Saline
- Keywords
- Intravenous Immunoglobulin, VGKC, Autoimmune epilepsy, Gamumex-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ImmunoglobulinDrug
Also called Gamunex-C
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.
PlacebosDrug
Also called Normal Saline
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 SalineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intravenous Immunoglobulin; Drug: Placebos; Drug: Normal Saline |
| Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group | Active comparator | Subjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds. Receives: Drug: Intravenous Immunoglobulin; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seizure Frequency From Baseline to 5 Weeks
The number of subjects who experience a ≥ 50% reduction in seizure frequency
Measured: baseline, 5 weeks
Secondary outcomes (1)
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)
Measured: baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autoimmune EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Shared Services North America, Inc., Option Care
- Responsible party
- Principal investigator, Sean Pittock, Mayo Clinic
- Investigators
- Sean Pittock, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697292
- Sponsor's protocol ID
- 15-005649
- Status last verified
- Dec 2019
- First submitted
- 19 Feb 2016
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Study of Intravenous Immunoglobulin (IVIG) Patients With Voltage Gated Potassium Channel Complex (VGKC) Antibody Associated Autoimmune Epilepsy
- ClinicalTrials.gov ID
- NCT02697292
- Acronym / sponsor ID
- 15-005649
- Conditions
- Autoimmune Epilepsy
- Keywords
- Intravenous Immunoglobulin, VGKC, Autoimmune epilepsy, Gamumex-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Grifols Shared Services North America, Inc., Option Care
- Study start
- Feb 2016
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Normal Saline Group | Placebo comparator | Drug: Intravenous Immunoglobulin, Drug: Placebos, Drug: Normal SalineSubjects 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 | Drug: Intravenous Immunoglobulin, Drug: Normal SalineSubjects will receive IVIG for 4 infusions. Subjects will maintain their stable dose of antiepileptic meds. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Seropositivity for Voltage Gated Potassium Channel Complex (VGKC) complex antibodies or positive for Leucine-Rich, Glioma Inactivated 1 (LGI1)/contactin-associated protein-like 2 (CASPR2) Antibody by cell based assay.
- And ≥ 2 seizures per week (mean of total over 1 week)
- And duration of epilepsy <3 years
- Male or female between the ages of 18 and 80 years of age
- Women and men of child bearing potential must agree to use a reliable form of contraception throughout the course of the study.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ImmunoglobulinAlso: Gamunex-CGAMUNEX-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. | Drug | Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group, Placebo/Normal Saline Group |
| PlacebosAlso: Normal SalineNormal 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. | Drug | Placebo/Normal Saline Group |
| Normal SalineNormal 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 | Drug | Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group, Placebo/Normal Saline Group |
Primary outcome
Change in Seizure Frequency From Baseline to 5 Weeks
Time frame: baseline, 5 weeks
The number of subjects who experience a ≥ 50% reduction in seizure frequency
1 secondary outcome
Change in Cognitive Assessment
Time frame: baseline, 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- PubMedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Pittock, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Immunoglobulin and Normal Saline in people with Autoimmune Epilepsy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seizure Frequency From Baseline to 5 Weeks (time frame: baseline, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.