Actively Recruiting

Age: 18Years +
All Genders
NCT03918421

Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study

Led by Hospices Civils de Lyon · Updated on 2026-01-20

45

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study. The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.

CONDITIONS

Official Title

Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fulfill international criteria for diagnosis of Immunoglobulin M (IgM) monoclonal gammopathy with anti-myelin-associated-glycoprotein (MAG) antibodies and peripheral neuropathy
  • Be 18 years of age or older
  • Provide informed consent and be followed in the neuromuscular department of Lyon
Not Eligible

You will not qualify if you...

  • Have diseases that might affect peripheral nerve or physical function such as diabetes, kidney failure, prior chemotherapy for other diseases, hereditary neuropathy, vitamin deficiency, connective tissue disorders, hepatitis B or C, HIV infection, or alcohol abuse exceeding 5 International Units per day
  • Have an active cancer with poor prognosis undergoing treatment other than for monoclonal gammopathy associated peripheral neuropathy
  • Are pregnant
  • Use medication that may affect peripheral nerve function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302

Bron, France, 69500

Actively Recruiting

2

Centre de référence NNERf

Le Kremlin-Bicêtre, France, 94275

Actively Recruiting

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Research Team

J

Juliette SVAHN, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study | DecenTrialz