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RecruitingNCT06334900Ata-GADUpdated Mar 28, 2024

Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia

An observational study in GAD-receptor Antibodies-associated Encephalitis, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • GAD-receptor Antibodies-associated Encephalitis

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03

In context

Encephalitis

125 studies on the registry are indexed under Encephalitis; 33 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 54 observational studies indexed under Encephalitis.

Browse Encephalitis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient with cerebellar ataxia and GAD antibody

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • neurological symptoms with GAD antibody
  • GAD antibody in sera and/or CSF
  • patient with cerebellar ataxia

Exclusion criteria

Exclusion Criteria:

  • tested positive to another antibody.
  • no data
  • any test in paraneoplastic neurological syndrome and encephalitis center
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: GAD patients

Interventions

  • OtherGAD patients

    Describe the clinical and demographic characteristics of patients with anti-GAD65 antibody associated cerebellar ataxia.

06

What researchers measure

Primary outcomes

  1. GAD Patient

    Description of clinical data in patients with cerebellar syndrome associated with anti-GAD antibodies

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
    Bron, 69677, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06334900
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Oct 1, 2023
Primary completion
Jan 1, 2024
Completion
Jun 30, 2024 (estimated)
Last update
Mar 28, 2024

Study contacts

Jérôme Honnorat, professor
Contact
jerome.honnorat@chu-lyon.fr
+33 4 72 35 78 06
Marine Villard, doctor
Contact
marine.villard@chu-lyon.fr
+33 4 27 85 54 60

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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