Anti-LGI1 EncephalitisevoLGI1NCT04106765
LGI1-antibody Patients Follow-up
An observational study of Anti-LGI1 Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-LGI1 Encephalitis
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 30 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population Description : Adult patients presenting an anti-LGI1 autoimmune encephalitis, followed in France and diagnosed by sera or CSF samples at the National Reference Center of autoimmune encephalitis.
Who may be able to join
- Age > 18 years
- Diagnosis of anti-LGI1 encephalitis based on sera or CSF samples in the National Reference Center of autoimmune encephalitis from 2011/06 to 2019 july 1st.
- Clinical follow-up in France
Who cannot join
- Anti-LGI1 antibody associated with another encephalitis antibody
- Foreign follow-up
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
Lyon
Jerome HONNORAT, PhD, 4 72 35 78 08 ext. 33, jerome.honnorat@chu-lyon.fr
About this study
Official title: Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.
This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.
- Conditions
- Anti-LGI1 Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| : epileptic LGI1-antibody patients | Patients affected by LGI1 antibody encephalitis presenting epileptic seizures as a first symptom Evaluated items: * Number of seizures * Type of seizures * Presence of EEG abnormalities * Presence of IRM abnormalities * Time before cognitive disorders | |
| cognitive LGI1-antibody patients | Patients affected by LGI1 antibody encephalitis presenting cognitive disorders as a first symptom Evaluated items: * Presence of EEG abnormalities * Presence of IRM abnormalities * Time before epileptic seizures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of epileptic seizures
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start30 Oct 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-LGI1 EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome HONNORAT, pHd, Principal investigator, National Reference Center of autoimmune encephalitis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106765
- Sponsor's protocol ID
- evoLGI1
- Acronym
- evoLGI1
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients
- ClinicalTrials.gov ID
- NCT04106765
- Acronym / sponsor ID
- evoLGI1 / evoLGI1
- Conditions
- Anti-LGI1 Encephalitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Sep 2019 (actual)
- 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.
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.
This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| : epileptic LGI1-antibody patients | – | –Patients affected by LGI1 antibody encephalitis presenting epileptic seizures as a first symptom Evaluated items: * Number of seizures * Type of seizures * Presence of EEG abnormalities * Presence of IRM abnormalities * Time before cognitive disorders |
| cognitive LGI1-antibody patients | – | –Patients affected by LGI1 antibody encephalitis presenting cognitive disorders as a first symptom Evaluated items: * Presence of EEG abnormalities * Presence of IRM abnormalities * Time before epileptic seizures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description : Adult patients presenting an anti-LGI1 autoimmune encephalitis, followed in France and diagnosed by sera or CSF samples at the National Reference Center of autoimmune encephalitis.
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of anti-LGI1 encephalitis based on sera or CSF samples in the National Reference Center of autoimmune encephalitis from 2011/06 to 2019 july 1st.
- Clinical follow-up in France
Key exclusion criteria (2 listed)
- Anti-LGI1 antibody associated with another encephalitis antibody
- Foreign follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of epileptic seizures
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- 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.
Jerome HONNORAT, pHd principal investigator
National Reference Center of autoimmune encephalitis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-LGI1 Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerome HONNORAT, PhD (4 72 35 78 08 ext. 33, jerome.honnorat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of epileptic seizures (time frame: 12 MONTHS). 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 15 Oct 2019.