GAD-receptor Antibodies-associated EncephalitisAta-GADNCT06334900
Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia
An observational study of GAD-receptor Antibodies-associated Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GAD-receptor Antibodies-associated Encephalitis
- What is being tested?
- GAD patients
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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
- Adult, Older adult
Study population: Patient with cerebellar ataxia and GAD antibody
Who may be able to join
- neurological symptoms with GAD antibody
- GAD antibody in sera and/or CSF
- patient with cerebellar ataxia
Who cannot join
- tested positive to another antibody.
- no data
- any test in paraneoplastic neurological syndrome and autoimmune encephalitis center
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
Bron, 69677
Jérôme Honnorat, professor, +33 4 72 35 78 06, jerome.honnorat@chu-lyon.fr
About this study
Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms.
- Being tested
- GAD patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAD patientsOther
Describe the clinical and demographic characteristics of patients with anti-GAD65 antibody associated cerebellar ataxia.
| Study group | Role | What they receive |
|---|---|---|
| Anti-GAD encephalitis | This is a non-interventional study involving clinical data. This data are information of medical follow up on patient like diagnosis, symptoms, biological results, cancer, treatments. Receives: Other: GAD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD Patient
Description of clinical data in patients with cerebellar syndrome associated with anti-GAD antibodies
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GAD-receptor Antibodies-associated 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334900
- Sponsor's protocol ID
- 69HCL24_0297
- Acronym
- Ata-GAD
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT06334900
- Acronym / sponsor ID
- Ata-GAD / 69HCL24_0297
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Mar 2024 (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.
Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-GAD encephalitis | – | Other: GAD patientsThis is a non-interventional study involving clinical data. This data are information of medical follow up on patient like diagnosis, symptoms, biological results, cancer, treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with cerebellar ataxia and GAD antibody
Key inclusion criteria (3 listed)
- neurological symptoms with GAD antibody
- GAD antibody in sera and/or CSF
- patient with cerebellar ataxia
Key exclusion criteria (3 listed)
- tested positive to another antibody.
- no data
- any test in paraneoplastic neurological syndrome and autoimmune encephalitis center
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 |
|---|---|---|
| GAD patientsDescribe the clinical and demographic characteristics of patients with anti-GAD65 antibody associated cerebellar ataxia. | Other | Anti-GAD encephalitis |
Primary outcome
GAD Patient
Time frame: Baseline
Description of clinical data in patients with cerebellar syndrome associated with anti-GAD antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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.
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 GAD-receptor Antibodies-associated 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 3 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 28 Mar 2024. 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 Jérôme Honnorat, professor (+33 4 72 35 78 06, 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?
GAD Patient (time frame: Baseline). 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 28 Mar 2024.