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Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multifocal Motor Neuropathy

Intervention: Subcutaneous immunoglobulin (Drug); Intravenous immunoglobulin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Henning Andersen, MD, DMSc, Principal Investigator, Affiliation: Aarhus University Hospital, Aarhus, Denmark
Johannes Jakobsen, Professor, Study Chair, Affiliation: Aarhus University Hospital

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 Details

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study

Primary outcome: Isokinetic muscle strength at the three most affected muscle groups.

Secondary outcome:

Medical research council score (MRC-score),

9-hole peg test,

10m walking,

Nerve conduction parameters,

SF-36

Adverse effects

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological

findings

Exclusion Criteria:

- Other severe medical conditions

- Pregnancy and lactation

- Anti-coagulation therapy

Locations and Contacts

Aarhus University Hospital, Department of Neyrology, Aarhus, Denmark
Additional Information

Starting date: August 2005
Ending date: February 2008
Last updated: February 19, 2008

Page last updated: June 20, 2008

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