Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
251 participants
OBSERVATIONAL
2015-02-03
2022-01-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Presence of Anti-RACH Antibodies and Neurocognitive Disorder in Myasthenic or Alzheimers's Patients.
NCT06523296
Study of Cortical Activation During Hand and Shoulder Movements in Healthy Subjects
NCT05691777
Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area
NCT05373394
Long-Term Motor Learning in Focal Hand Dystonia
NCT00325091
Cerebral Activation and Apprehension in Patients With Shoulder Instability.
NCT06157788
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At inclusion the SSN diagnostic score is calculated and a blood sample is tested for anti-FGFR3 antibody.
Follow up: Patients positive for anti-FGFR3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. A blood sample is taken at 6 and 12 months.
A subgroup of patients negative for anti-FGFR3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patient
Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and positive for anti-FGFR3 antibodies. These patients will have Neurological assessment and Blood sample.
Neurological assessment and Blood sample
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
control
Male or female patient aged 18 years with a clinically pure sensory peripheral neuropathy and negative for anti-FGFR3 antibodies
Neurological assessment and Blood sample
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neurological assessment and Blood sample
Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Patients with a clinically pure sensory peripheral neuropathy including :
* idiopathic or dysimmune sensory neuronopathies
* idiopathic or dysimmune distal axonal sensory neuropathy
* sensory chronic inflammatory demyelinating polyradiculoneuropathy
* idiopathic or dysimmune small fiber neuropathies
* idiopathic or dysimmune trigeminal nerve neuropathy
* positive to antibodies anti-FGFR3
B :Controls Male or female patient aged 18 years or more
Patients with a clinically pure sensory peripheral neuropathy including :
* idiopathic or dysimmune sensory neuronopathies
* idiopathic or dysimmune distal axonal sensory neuropathy
* sensory chronic inflammatory demyelinating polyradiculoneuropathy
* idiopathic or dysimmune small fiber neuropathies
* idiopathic or dysimmune trigeminal nerve neuropathy
* negative to antibodies anti-FGFR3
Exclusion Criteria
* Genetic, toxic, paraneoplasic neuropathies
* Diabetic Neuropathy.
* Neuropathy with Anti-MAG or anti-ganglioside IgM.
* Pregnant or breastfeeding woman
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Christophe ANTOINE, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Bordeaux
Bordeaux, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Chu Creteil
Créteil, , France
CHU de Grenoble
Grenoble, , France
CHU de Limoges
Limoges, , France
Hospices Civils de Lyon
Lyon, , France
AP-HM
Marseille, , France
CHRU de Nantes
Nantes, , France
CHU de NICE
Nice, , France
Hôpital BICETRE
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
Fondation Rothschild
Paris, , France
CHU Poitiers
Poitiers, , France
CH Cornouailles
Quimper, , France
CH Saint Denis - Hôpital Delafontaine
Saint-Denis, , France
Chu Saint-Etienne
Saint-Etienne, , France
Chu Strasbourg
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassabliere F, Reynaud-Federspiel E, Franca MC Jr, Martinez ARM, Camdessanche JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-A00636-41
Identifier Type: OTHER
Identifier Source: secondary_id
1408060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.