Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Multifocal Motor Neuropathy Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multifocal Motor Neuropathy
• Neuritis

• NCT number: NCT00268788
• Study type: Interventional
• Source: University of Aarhus
• Status: Completed
• Phase: Phase 2
• Start date: August 2005
• Completion date: February 2008