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NCT03918421

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

Recruiting now Last updated 20 January 2026
What this trial tests

trial testing Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS) in Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy in 45 participants. Currently enrolling.

Timeline
23 June 2020
Primary endpoint
23 June 2030
23 June 2030

Quick facts

Lead sponsorHospices Civils de Lyon
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment45
Start date23 June 2020
Primary completion23 June 2030
Estimated completion23 June 2030
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Hospices Civils de Lyon trials

Trials by the same sponsor.

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Data sources for this page

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