- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06334900
Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia (Ata-GAD)
March 21, 2024 updated by: Hospices Civils de Lyon
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marine Villard, doctor
- Phone Number: +33 4 27 85 54 60
- Email: marine.villard@chu-lyon.fr
Study Contact Backup
- Name: Jérôme Honnorat, professor
- Phone Number: +33 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69677
- Recruiting
- Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
-
Contact:
- Jérôme Honnorat, professor
- Phone Number: +33 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patient with cerebellar ataxia and GAD antibody
Description
Inclusion Criteria:
- neurological symptoms with GAD antibody
- GAD antibody in sera and/or CSF
- patient with cerebellar ataxia
Exclusion Criteria:
- tested positive to another antibody.
- no data
- any test in paraneoplastic neurological syndrome and autoimmune encephalitis center
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Describe the clinical and demographic characteristics of patients with anti-GAD65 antibody associated cerebellar ataxia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GAD Patient
Time Frame: Baseline
|
Description of clinical data in patients with cerebellar syndrome associated with anti-GAD antibodies
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
March 21, 2024
First Submitted That Met QC Criteria
March 21, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_0297
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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