Study on IgM-anti-MAG peripheral neuropathy

Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre

This study is trying to gather information from 25 patients with IgM-anti-MAG peripheral neuropathy to better understand their symptoms and treatments, which will help create a new scale to measure their disability.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Bron and 1 other locations)
• Trial ID: NCT03918421 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect standardized clinical data from 25 patients diagnosed with IgM-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The study will detail various clinical subtypes, treatment responses, and antibody titers using multiple outcome measures. The data collected will contribute to the development of a specific Rasch-built overall Disability Scale (RODS) tailored for this condition, ensuring it meets modern clinimetric standards, including cross-cultural validity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who meet the diagnostic criteria for IgM monoclonal gammopathy with anti-MAG antibodies and peripheral neuropathy.

Not a fit: Patients with concomitant diseases that interfere with peripheral nerve function or those with active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved assessment and treatment strategies for patients with IgM-anti-MAG peripheral neuropathy.

How similar studies have performed: While there is limited consensus on treatment approaches for this condition, the study aims to build upon existing knowledge, suggesting a potential for success based on prior observational data.

Eligibility criteria

Inclusion Criteria:

* fulfilling the international criteria for the diagnosis Immunogloblin M (IgM) monoclonal gammopathy, with anti-myelin-associated-glycoprotein (MAG) antibodies, and peripheral neuropathy.
* age of 18 years or older followed in neuromuscular department of Lyon;
* informed consent given by the participant

Exclusion Criteria:

* concomitant diseases possibly interfering with peripheral nerve and function, as well as physical functioning, such as diabetes, renal insufficiency, (prior) treatment with chemotherapy for diseases other than their Immunogloblin M (IgM) monoclonal gammopathy associated peripheral neuropathy, history of hereditary neuropathy, vitamin deficiency, connective tissue disorder, hepatitis B and C and human immunodeficiency virus (HIV) infection, alcohol abuse (more than 5 International Units(IU)/day);
* an active malignancy with poor prognosis, undergoing treatment aside from monoclonal gammopathy associated peripheral neuropathy;
* pregnant;
* the use of any medication that may cause peripheral nerve function

Where this trial is running

Bron and 1 other locations

• Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302 — Bron, France (RECRUITING)
• Centre de référence NNERf — Le Kremlin-Bicêtre, France (RECRUITING)

Study contacts

• Principal investigator: Juliette SVAHN, MD — Hospices Civils de Lyon
• Study coordinator: Juliette SVAHN, MD

Conditions: Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy