NCT00268788

Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Multifocal Motor Neuropathy

Interventions

Type	Name	Description
DRUG	Subcutaneous immunoglobulin	Individually dosed, given twice a week.
DRUG	Intravenous immunoglobulin	Individual dose and frequency

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-12-22
• Last updated: 2008-02-21

Locations

1 site across 1 country: Denmark