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Not yet recruitingNCT07794137PREDIMAGUpdated Aug 31, 2026

Study Evaluating the Predictive Value of the Terminal Latency Index (TLI) for Treatment Response in Patients With Anti-MAG Neuropathy

An observational study in Anti-MAG Neuropathy, Peripheral Nervous System Disease and Anti-Myelin-Associated Glycoprotein Antibodie, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Peripheral Nervous System Diseases with a site in France — 7 open to participants now, 9 under way, 2 of them phase 3. Peripheral Nervous System Diseases · France.

Started
2026
with 2 others
Observational
5 of 31
3 open now
Registered
31st of 31
by date

Among the 31 studies in Peripheral Nervous System Diseases with a site in France, this one is one of 3 that started in 2026, is one of 5 observational ones, and was the 31st registered.

Peripheral Nervous System Diseases

476 studies on the registry are indexed under Peripheral Nervous System Diseases; 103 are open to participants now.

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Open to participants now

7 of the 31 studies in Peripheral Nervous System Diseases with a site in France are open now. Recruiting first, the newest first:

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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 →

Who these studies take

Of the 65 Peripheral Nervous System Diseases studies recruiting now, 44 (68%) set no upper age limit and 10 (15%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study summary

"Anti-myelin-associated glycoprotein (anti-MAG) neuropathy is a rare dysimmune peripheral neuropathy, most commonly associated with an IgM monoclonal gammopathy. Its course is generally slow but may lead to significant functional disability. Despite therapeutic advances, including rituximab, intravenous immunoglobulins (IVIg), immunochemotherapy, and more recently Bruton tyrosine kinase inhibitors (BTKi), treatment response remains highly variable between patients. The Terminal Latency Index (TLI), an electrophysiological parameter reflecting distal demyelination, is a recognized diagnostic marker of anti-MAG neuropathy. However, its potential role as a predictive biomarker of treatment response remains insufficiently studied. Identifying a simple, reproducible, and readily available biomarker that could predict treatment response would be of major clinical importance for personalized patient management and optimization of therapeutic strategies. This monocentric retrospective study will analyze clinical, biological, and electrophysiological data from patients with anti-MAG neuropathy followed at Nice University Hospital (CHU de Nice) to assess the predictive value of baseline TLI for clinical response 12 months after treatment initiation."

03

Conditions studied

  • Anti-MAG Neuropathy
  • Peripheral Nervous System Disease
  • Anti-Myelin-Associated Glycoprotein Antibodie
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

"Adult patients with documented anti-MAG activity-associated neuropathy, followed at the Reference Center for Rare Diseases of the Peripheral Nervous System at Nice University Hospital (CHU de Nice) between January 2005 and July 2025. Planned number of participants: 100 patients."

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

  • Documented anti-MAG IgM polyneuropathy: positive anti-MAG antibodies, associated with an IgM monoclonal gammopathy, and a compatible clinical phenotype.
  • Complete and interpretable baseline ENMG assessment: an initial electroneuromyography (ENMG) examination allowing reliable calculation of the TLI in at least two motor nerves among the right median, ulnar, and common fibular nerves.
  • The examination must include the distal motor latency, proximal motor conduction velocity, and compound muscle action potential (CMAP).
  • Treatment with at least one established therapeutic strategy: treatment initiated at the center, including intravenous immunoglobulins (IVIg), rituximab, immunochemotherapy, Bruton tyrosine kinase inhibitors (BTKi), and/or symptomatic treatment.
  • Available functional clinical assessment: a documented INCAT disability score at two predefined time points: baseline (before treatment initiation) and 12 months (±2 months) after treatment initiation.
  • Consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Peripheral neuropathy associated with an IgM monoclonal gammopathy, with strictly negative anti-MAG antibody testing or no available anti-MAG antibody measurement.
  • Incomplete or uninterpretable ENMG data preventing accurate calculation of the TLI for the nerves of interest (median and ulnar nerves).
  • Absence of a formally documented INCAT score at baseline or within the 12-month assessment window.
05

Study design

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

Groups and cohorts

  • Anti-myelin-associated glycoprotein (anti-MAG) neuropathy

    This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice). No additional intervention or modification of routine clinical care will be performed. Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives. Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula. The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed. Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded. No treatment will be assigned or modified by the study. Data will be pseudonymized and ent

    Diagnostic Test: Electroneuromyography (ENMG) and Terminal Latency Index (TLI) Assessment

Interventions

  • Diagnostic testElectroneuromyography (ENMG) and Terminal Latency Index (TLI) Assessment

    This monocentric retrospective observational study will include 100 patients with anti-myelin-associated glycoprotein (anti-MAG) neuropathy followed at Nice University Hospital (CHU de Nice). No additional intervention or modification of routine clinical care will be performed. Clinical, biological, therapeutic, and electrophysiological data will be retrospectively collected from medical records and available archives. Routinely performed electroneuromyography (ENMG) data will be analyzed, with particular emphasis on the Terminal Latency Index (TLI), calculated from available electrophysiological parameters according to the standard formula. The predictive value of baseline TLI for clinical response to treatment at 12 months will be assessed. Treatments received as part of routine care, including rituximab, IVIg, immunochemotherapy, and Bruton tyrosine kinase inhibitors (BTKi), will be recorded. No treatment will be assigned or modified by the study. Data will be pseudonymized and ente

06

What researchers measure

Primary outcomes

  1. Favorable Clinical Response at 12 Months (≥1-Point Decrease in INCAT Score)

    Clinical response at 12 months, defined as a reduction of at least 1 point in the INCAT disability score from baseline. This outcome will be used to assess the predictive value of the baseline Terminal Latency Index (TLI) for treatment response in patients with anti-MAG neuropathy.

    Time frame: 12 months after treatment initiation

Secondary outcomes

  1. Predictive performance of TLI according to treatment strategy

    Assessment of the predictive performance of baseline TLI for clinical response at 12 months, stratified according to the treatment strategy received.

    Time frame: 12 months after treatment initiation.

  2. Correlation between TLI, anti-MAG antibody titer, and INCAT score evolution

    Assessment of the association between baseline TLI, quantitative anti-MAG antibody titer, and change in the INCAT disability score from baseline to 12 months.

    Time frame: Baseline to 12 months after treatment initiation

  3. Optimal TLI threshold for predicting treatment response

    Determination of the optimal baseline TLI threshold for predicting clinical response at 12 months using Receiver Operating Characteristic (ROC) curve analysis and the Youden index

    Time frame: Baseline to 12 months after treatment initiation

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07794137
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 31, 2026

Study contacts

Mecheli Cavalli
Contact
puma.ar@chu-nice.fr
0492035435 ext. +33
Abderhmane Slioui
Contact
slioui.a@chu-nice.fr
0492038953 ext. +33
Mecheli Cavalli
principal investigator

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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