Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Phase 2

Completed

• Conditions: Multifocal Motor Neuropathy
• Interventions: Drug: Subcutaneous immunoglobulin; Drug: Intravenous immunoglobulin

• Registration Number: NCT00268788
• Lead Sponsor: University of Aarhus

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 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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-22
• Status Verified: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-19
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings

Exclusion Criteria

• Other severe medical conditions
• Pregnancy and lactation
• Anti-coagulation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Subcutaneous immunoglobulin	Subcutaneous Ig given twice a week.
2	Intravenous immunoglobulin	Intravenous Ig

Primary Outcome Measures

Name	Time	Method
Isokinetic muscle strength at the three most affected muscle groups.	At the end of each arm of the crossover study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Neyrology; 🇩🇰 Aarhus, Denmark