CASPR2-AntibodyiniCASPR2NCT04653571
CASPR2 Encephalitis Initial Symptoms
An observational study of CASPR2-Antibody and Encephalitis Autoimmune, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2. CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CASPR2-Antibody, Encephalitis Autoimmune, Paraneoplastic Syndromes
- What is being tested?
- CASPR2 encephalitis
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2021to 20 Jan 2022
- 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: Patients with a CASPR2 antibody-associated auto-immune encephalitis
Who may be able to join
- Positive CASPR2-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing CASPR2.
- Diagnosis and follow-up in France
- From 18 to unlimited age
Who cannot join
- Patients CASPR2-IgG negative in serum and CSF
- Foreign follow-up
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neuro-Oncologie, Hôpital Neurologique Pierre Wertheimer
Bron, 69500
About this study
Official title: Defining the Initial Clinical Symptoms and Characterizing Those Leading to the Discovery of CASPR2
Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.
CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. Most patients are initially hospitalized because of the temporal seizures (Joubert et al., JAMA Neurology 2016). However, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis.
Read more
The study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a CASPR2 antibody-associated encephalitis, from the French reference center on paraneoplastic neurological diseases and autoimmune encephalitis.
This way, the study aims to delineate the symptoms that should trigger suspicions of a CASPR2 antibody-associated encephalitis
- Being tested
- CASPR2 encephalitis
- Keywords
- antibody ; auto-immune encephalitis ; paraneoplastic syndrome ; CASPR2
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Paraneoplastic Syndromes, Cortical Dysplasia-Focal Epilepsy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASPR2 encephalitisOther
Defining the initial clinical symptoms and those leading to the diagnosis of CASPR2 antibody associated encephalitis. For that, we will investigate the initial cognitive status, the initial neuropsychological investigations the clinical presentation of the first seizures, and the prodromes assessed by patients at the beginning of their disease. We will also look at the initial EEG records, in order to acknowledge whether the initial cognitive symptoms may be due to unseen seizures.
| Study group | Role | What they receive |
|---|---|---|
| CASPR2 encephalitis | Cohort of patients with a CASPR2 antibody-associated auto-immune encephalitis. Receives: Other: CASPR2 encephalitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial cognitive impairment or clinical presentation of first epileptic seizures.
The retained information will depend on the very first declared symptom: if the patient first showed focal seizures, we will precise the clinical presentation of this seizure. On the other hand, if the patient first showed cognitive symptoms, we will best define this impairment.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start11 Jan 2021
- Primary completion30 Mar 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CASPR2-AntibodyStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme HONNORAT, Pr, Principal investigator, Service de neuro-oncologie, Hôpital neurologique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653571
- Sponsor's protocol ID
- 69HCL20_0760
- Acronym
- iniCASPR2
- Status last verified
- Feb 2022
- First submitted
- 27 Nov 2020
- Last updated
- 4 Feb 2022
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Initial Clinical Symptoms and Characterizing Those Leading to the Discovery of CASPR2
- ClinicalTrials.gov ID
- NCT04653571
- Acronym / sponsor ID
- iniCASPR2 / 69HCL20_0760
- Keywords
- antibody ; auto-immune encephalitis ; paraneoplastic syndrome ; CASPR2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 4 Dec 2020 (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.
Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.
CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. Most patients are initially hospitalized because of the temporal seizures (Joubert et al., JAMA Neurology 2016). However, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis.
The study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a CASPR2 antibody-associated encephalitis, from the French reference center on paraneoplastic neurological diseases and autoimmune encephalitis.
This way, the study aims to delineate the symptoms that should trigger suspicions of a CASPR2 antibody-associated encephalitis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CASPR2 encephalitis | – | Other: CASPR2 encephalitisCohort of patients with a CASPR2 antibody-associated auto-immune encephalitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a CASPR2 antibody-associated auto-immune encephalitis
Key inclusion criteria (3 listed)
- Positive CASPR2-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing CASPR2.
- Diagnosis and follow-up in France
- From 18 to unlimited age
Key exclusion criteria (2 listed)
- Patients CASPR2-IgG negative in serum and CSF
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASPR2 encephalitisDefining the initial clinical symptoms and those leading to the diagnosis of CASPR2 antibody associated encephalitis. For that, we will investigate the initial cognitive status, the initial neuropsychological investigations the clinical presentation of the first seizures, and the prodromes assessed by patients at the beginning of their disease. We will also look at the initial EEG records, in order to acknowledge whether the initial cognitive symptoms may be due to unseen seizures. | Other | CASPR2 encephalitis |
Primary outcome
Initial cognitive impairment or clinical presentation of first epileptic seizures.
Time frame: 8 months
The retained information will depend on the very first declared symptom: if the patient first showed focal seizures, we will precise the clinical presentation of this seizure. On the other hand, if the patient first showed cognitive symptoms, we will best define this impairment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for CASPR2-Antibody
RecruitingObservational study
Medium-term Effects of Treatments in Autoimmune Encephalitis
NMDAR Autoimmune Encephalitis, LGI1 Antibody Associated Encephalitis
RecruitingObservational study
Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)
Optic Neuritis, Transverse Myelitis
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.
Jérôme HONNORAT, Pr principal investigator
Service de neuro-oncologie, Hôpital neurologique
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 CASPR2-Antibody and Encephalitis Autoimmune, 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: finished, as of the sponsor's last update on 4 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Initial cognitive impairment or clinical presentation of first epileptic seizures. (time frame: 8 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 4 Feb 2022.