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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268788
• Other study ID #: 2005-130
• Secondary ID: EudraCT-number:
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: February 19, 2008
• Start date: August 2005
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Intervention

Drug:
• Subcutaneous immunoglobulin
Individually dosed, given twice a week.
• Intravenous immunoglobulin
Individual dose and frequency

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Neyrology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic muscle strength at the three most affected muscle groups.		At the end of each arm of the crossover study	No
Secondary	Medical research council score (MRC-score),		At the end of each treatment arm of the crossover study	No
Secondary	9-hole peg test,		At the end of each treatment arm of the crossover study	No
Secondary	10m walking,		At the end of each treatment arm of the crossover study	No
Secondary	Nerve conduction parameters,		At the end of each treatment arm of the crossover study	No
Secondary	SF-36		At the end of each treatment arm of the crossover study	No
Secondary	Adverse effects		During each treatment arm of the crossover study	Yes