Autoimmune EncephalopathyNCT03003143
Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients
A study testing Vigabatrin 500 MG in people with Autoimmune Encephalopathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Autoimmune Encephalopathy
- What is being tested?
- Vigabatrin 500 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- Possible autoimmune encephalitis
- Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
- Patients with epilepsy (EEG finding or clinically)
Who cannot join
- septic shock, fever >38.5 ℃, O2 saturation <90%, respiratory rate >25, HR >120
- previously, mRS=3 or mRS>3
- MMSE<20
- Patients who have terminal disease
- eye problem
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients
- Conditions
- Autoimmune Encephalopathy
- Being tested
- Vigabatrin 500 MG
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigabatrin 500 MGDrug
| Study group | Role | What they receive |
|---|---|---|
| Vigabatrin treatment group | Experimental | Not described Receives: Drug: Vigabatrin 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency reduction
50% reduction - favorable outcome
Measured: 3 month of vigabatrin administration
Secondary outcomes (5)
Modified Rankin Scale
Measured: 3 month of vigabatrin administration
Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
Measured: after 3 month of vigabatrin administration
Depression (Beck Depression Inventory®-II)
Measured: 3 month of vigabatrin administration
Cognition (Mini-Mental State Examination-Korean)
Measured: 3 month of vigabatrin administration
Sleep quality (Pittsburgh Sleep Quality Assessment)
Measured: 3 month of vigabatrin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune EncephalopathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kon Chu, Seoul National University Hospital
- Investigators
- KON CHU, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003143
- Sponsor's protocol ID
- 1607092776
- Status last verified
- Sep 2021
- First submitted
- 13 Dec 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
Publications
Bjurstom H, Wang J, Ericsson I, Bengtsson M, Liu Y, Kumar-Mendu S, Issazadeh-Navikas S, Birnir B. GABA, a natural immunomodulator of T lymphocytes. J Neuroimmunol. 2008 Dec 15;205(1-2):44-50. doi: 10.1016/j.jneuroim.2008.08.017. Epub 2008 Oct 26.
PubMed 18954912Rossi S, Muzio L, De Chiara V, Grasselli G, Musella A, Musumeci G, Mandolesi G, De Ceglia R, Maida S, Biffi E, Pedrocchi A, Menegon A, Bernardi G, Furlan R, Martino G, Centonze D. Impaired striatal GABA transmission in experimental autoimmune encephalomyelitis. Brain Behav Immun. 2011 Jul;25(5):947-56. doi: 10.1016/j.bbi.2010.10.004. Epub 2010 Oct 20.
PubMed 20940040
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT03003143
- Acronym / sponsor ID
- 1607092776
- Conditions
- Autoimmune Encephalopathy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vigabatrin treatment group | Experimental | Drug: Vigabatrin 500 MG |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-85
- Possible autoimmune encephalitis
- Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
- Patients with epilepsy (EEG finding or clinically)
Key exclusion criteria (6 listed)
- septic shock, fever >38.5 ℃, O2 saturation <90%, respiratory rate >25, HR >120
- previously, mRS=3 or mRS>3
- MMSE<20
- Patients who have terminal disease
- eye problem
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 |
|---|---|---|
| Vigabatrin 500 MG | Drug | Vigabatrin treatment group |
Primary outcome
Seizure frequency reduction
Time frame: 3 month of vigabatrin administration
50% reduction - favorable outcome
5 secondary outcomes
Modified Rankin Scale
Time frame: 3 month of vigabatrin administration
Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
Time frame: after 3 month of vigabatrin administration
Depression (Beck Depression Inventory®-II)
Time frame: 3 month of vigabatrin administration
Cognition (Mini-Mental State Examination-Korean)
Time frame: 3 month of vigabatrin administration
Sleep quality (Pittsburgh Sleep Quality Assessment)
Time frame: 3 month of vigabatrin administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 18954912Bjurstom H, Wang J, Ericsson I, Bengtsson M, Liu Y, Kumar-Mendu S, Issazadeh-Navikas S, Birnir B. GABA, a natural immunomodulator of T lymphocytes. J Neuroimmunol. 2008 Dec 15;205(1-2):44-50. doi: 10.1016/j.jneuroim.2008.08.017. Epub 2008 Oct 26.
- Background: PubMed 20940040Rossi S, Muzio L, De Chiara V, Grasselli G, Musella A, Musumeci G, Mandolesi G, De Ceglia R, Maida S, Biffi E, Pedrocchi A, Menegon A, Bernardi G, Furlan R, Martino G, Centonze D. Impaired striatal GABA transmission in experimental autoimmune encephalomyelitis. Brain Behav Immun. 2011 Jul;25(5):947-56. doi: 10.1016/j.bbi.2010.10.004. Epub 2010 Oct 20.
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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.
KON CHU, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigabatrin 500 MG in people with Autoimmune Encephalopathy, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Sep 2021. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Seizure frequency reduction (time frame: 3 month of vigabatrin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003143, which also lists 2 linked publications.
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 29 Sep 2021.