Clinical Trial: Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: University of Aarhus

Current Primary Outcome: Isokinetic muscle strength at the three most affected muscle groups. [ Time Frame: At the end of each arm of the crossover study ]

Original Primary Outcome:

Current Secondary Outcome:

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


Original Secondary Outcome:

Information By: University of Aarhus

Dates:
Date Received: December 21, 2005
Date Started: August 2005
Date Completion:
Last Updated: February 19, 2008
Last Verified: February 2008