An observational study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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Among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France — 8 open to participants now, 10 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · France.
Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is one of 4 that started in 2022, is one of 9 observational ones, and was the 28th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →8 of the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France are open now. Recruiting first, the newest first:
argenx · Sites in France, United States, Argentina and 22 more countries
Ages 18+
argenx · Sites in France, United States, Argentina and 28 more countries
Ages 18+
Dianthus Therapeutics · Sites in France, United States, Argentina and 28 more countries
Ages 18–75
Sanofi · Sites in France, United States, Argentina and 21 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in France, United States, Argentina and 16 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 16
First in 2004; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is close to the median of 49 across 44 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 82 across the 29 interventional studies, 45 across the 9 observational. Of the 25 that completed or were terminated, 12 (48%) have results posted.
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23 of 38 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Centre Hospitalier Universitaire de Nice has 3 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
5 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT04280718argenxA Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | 2027-04-30 |
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Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The use of neuroimaging in the evaluation of neuromuscular pathologies is a promising and rapidly expandinf field. Among the different imaging techniques employed, nerve ultrasound is of particular interest given it's non invasivity, lack of side effects, accesibility and low cost. This exam provides complementary data to electroneuromyography (ENMG), enabeling the physician to visualise the morphological correspondents of electrophysiological abnormalities with a spatial resolution at least as good as MRI.
Chronic Inflammatory Demyelinating Polyradiculoneuritis (CIDP), Multifocal Motor Neuropathy with Conduction Blocks (MMNBC), Lewis and Sumner syndrome (L-S syndrome) and anti-MAG antibody-associated neuropathies (anti-MAG) are among the main chronic inflammatory neuropathies of autoimmune etiology. The diagnosis of these diseases is based on clinical, paraclinical and ENMG examinations. Several recent studies have highlighted the valuable role of ultrasound not only in the diagnosis but also for follow up of patients afflicted by this group of diseases.
However, the current ultrasound imaging techniques does not allow for a detailed study of the internal structure of the nerves. The developement of technologies with improved resolution contribute to further the knowledge in this innovative field and to better understand the pathophysiological mechanisms responsible for initiation and progression of inflammatory nerve disorders.In the Department of Ultrasound at the Nice University Hospital in France the team have at its disposal a high frequency untrasound that the team use to explore the peripheral nervous system.
The scientific hypothesis of this pilot study rests on the premise that demyelinationg neuropathies are a heterogenous group where different types present with different morphological characteristics not only at the level of the nerve as a whole, but also at the level of the nerve fascicles and of the peri- and intra-neural vascular structures. In this respect, high frequency ultrasound allows us to visualise different segments of affected nerves and to obtain morphological details which the team then compare with existing ultrasound data in the literature (high frequency ultrasound: 10-20 MHz). Thanks to this non-invasive and painless technique, the nerve can be rapidly visualised along its entire length in static and dynamic mode. In addition, high frequency ultrasound will give us access to complementary data on the morphology of the soft tissues and the peri- and intra-neural vascular structures which may be useful in shedding light on the underlying pathophysiologycal processes. Another important aspect is the opportunity to make electromyographic and clinical correlations The main parameter The team will study in ultrasound will be hypertrophy, corresponding to an increase in the cross-sectional area of the nerve. the team will also conduct analysis on other less codified parameters, such as epineural and endoneural vascularisation (using the Doppler mode), as well as nerve fascicles anatomy (size, organisation). Identification of different characteristics may be of diagnostic interest in cases where the clinical, paraclinical and ENMG examinations do not allow us to make a diagnostic and therapeutic decision, but it can also prove useful in the follow-up of patients and response to treatment.
This is a descriptive, pilot, mono-centric, multiparametric and retrospective analysis study on patients followed in our centre with a diagnosis of CIDP, NMMBC, L-S syndrom and anti-MAG
The patients in this study came to the Nice University Hospital in the Peripheral Nervous System and Muscle (SNPM) department for a consultation in the context of neuropathy. They were diagnosed with CIDP, MMNBC, anti-MAG and L-S and have undergone an ultrasound in addition to standard diagnosis protocol.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CIDP, is an acquired chronic inflammatory neuropathy characterised by : progressive symmetrical weakness of the proximal and to a lesser extent distal muscles of the lower and/or upper limbs, altered sensitivity and a decrease/abolition of the osteotendinous reflexes. The condition can be relapsing (30% of cases), chronically progressive (60%), or monophasically with total subsequent recovery (10%). Cranial nerve involvement is possible (5-30% of cases). Neuropathic pain as well as respiratory muscle and sub-clinical central nervous system involvement are described.
Other: high frequency ultrasound
Patients with MMNCB are at the crossroads between chronic demyelinating neuropathies and motor neuron diseases, the latter for which they constitute a differential diagnosis. The disease usually presents asymmetrically and affects the upper limbs more frequently. The course of the disease is unpredictable, and may be limited to one or two motor nerves or progress to other motor nerves in the contralateral upper limb and possibly the lower limbs. In all cases, the motor deficit is asymmetrical, multi-truncular in distribution, and is usually accompanied by cramps and fasciculations, and eventually by amyotrophy. Osteotendinous reflexes are usually diminished or abolished in the affected areas, but they may also be preserved in the initial attacks. There is no sensory deficit, although some patients occasionally present with paresthesias, and exceptionally with damage to the cranial nerves (especially CN XII).
Other: high frequency ultrasound
Anti-MAG is a demyelinating neuropathy characterized clinically by a chronic progressive distal and symmetrical predominantly sensory involvement. This neuropathy belongs to the group of symmetrical acquired demyelinating neuropathies (Distal Acquired Demyelinating Neuropathy (DADS)) which is distinguished from PIDC by: 1. an essentially distal and rather sensitive clinical involvement (unlike PIDC which is proximal and distal with predominantily motor involvement); 2. a strong association with a monoclonal gammopathy of the IgM type (67% of DADS vs 22% of PIDC according to Katz et al, 3. a poor therapeutic response to first line of immunosuppressive drugs (in contrast to PIDC which generally responds well). Certain electrophysiological parameters, such as the demonstration of demyelinating damage with accentuated slowing of distal nerve conduction, make it possible to distinguish anti-MAG neuropathy from CIDP.
Other: high frequency ultrasound
Lewis-Sumner syndrome is an acquired demyelinating polyradiculoneuritis characterised by distal asymmetric upper and lower limb weakness and motor dysfunction that develops in adulthood. It is considered a variant of chronic inflammatory demyelinating polyradiculoneuritis. It has a prevalence of 1-9 per 1,000,000. The diagnosis is made with electroneuromyography (ENMG) which shows marked and persistent conduction blocks, in at least two nerves, having an asymmetric topography, mainly affecting the upper limb, outside the usual areas of compression. Lower limb blocks are much rarer (anterior tibial nerve), and are always located below the fibular neck.
Other: high frequency ultrasound
high frequency ultrasound in subgroups of patients with CIDP, anti-MAG, NMMBC and L-S syndrome
Analysis of nerve size using high frequency ultrasound
Size of cross section area (CSA) (mm) mesured in trasversal section of median and ulnar nerves at wrist, elbow and middle arm
Time frame: 24 months
correlation between ultrasound data and clinical data
The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of motor deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - MRC-score allowing the assessment of the motor deficit. -
Time frame: 24 months
correlation between ultrasound data and clinical data
The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of sensory deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - INCAT for the evaluation of sensory deficit.
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Distal latency (in milliseconds);
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Motor conduction velocity (in m/s);
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Total and partial conduction block (reduction in the area and amplitude of the global muscle action potential expressed in percentage));
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Reduction in the amplitude of the global muscle action potential (amplitude in mV)
Time frame: 24 months
Plan to share: No
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Ran from Jan 2022 to primary completion in Jan 2022, 0 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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