Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy NB. ONLY RECRUITING FROM DENMARK

Detailed Description
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Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance patients require lifelong treatment. Hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. However patients with MMN have not previously been treated with subcutaneous immunoglobulin. Hypothesis: Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience. Primary endpoint: Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.) Secondary endpoint: Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction parameters, SF-36.

Official Title
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A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy

Conditions
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Multifocal Motor Neuropathy

Intervention / Treatment
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* Drug: Subcutaneous immunoglobulin
* Drug: Intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings Exclusion Criteria: Other severe medical conditions Pregnancy and lactation Anti-coagulation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subcutaneous Ig given twice a week. | Drug: Subcutaneous immunoglobulin<br>* Individually dosed, given twice a week.<br>* Other names: Subcuvia;|
| Active Comparator: 2<br>Intravenous Ig | Drug: Intravenous immunoglobulin<br>* Individual dose and frequency<br>* Other names: Endobulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic muscle strength at the three most affected muscle groups. |  | At the end of each arm of the crossover study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical research council score (MRC-score), |  | At the end of each treatment arm of the crossover study | 
| 9-hole peg test, |  | At the end of each treatment arm of the crossover study | 
| 10m walking, |  | At the end of each treatment arm of the crossover study | 
| Nerve conduction parameters, |  | At the end of each treatment arm of the crossover study | 
| SF-36 |  | At the end of each treatment arm of the crossover study | 
| Adverse effects |  | During each treatment arm of the crossover study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin