Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

NCT ID: NCT00268788

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-02-29

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.

Conditions

Multifocal Motor Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Subcutaneous Ig given twice a week.

Group Type: ACTIVE_COMPARATOR

Subcutaneous immunoglobulin

Intervention Type: DRUG

Individually dosed, given twice a week.

2

Intravenous Ig

Group Type: ACTIVE_COMPARATOR

Intravenous immunoglobulin

Intervention Type: DRUG

Individual dose and frequency

Interventions

Subcutaneous immunoglobulin

Individually dosed, given twice a week.

Intervention Type: DRUG

Intravenous immunoglobulin

Individual dose and frequency

Intervention Type: DRUG

Other Intervention Names

Subcuvia; Endobulin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital

Principal Investigators

Henning Andersen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Johannes Jakobsen, Professor

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

Aarhus University Hospital, Department of Neyrology

Aarhus, , Denmark

Countries

Denmark

References

Harbo T, Andersen H, Hess A, Hansen K, Sindrup SH, Jakobsen J. Subcutaneous versus intravenous immunoglobulin in multifocal motor neuropathy: a randomized, single-blinded cross-over trial. Eur J Neurol. 2009 May;16(5):631-8. doi: 10.1111/j.1468-1331.2009.02568.x. Epub 2009 Feb 19.

Reference Type: DERIVED

PMID: 19236457 (View on PubMed)

Other Identifiers

EudraCT-number: 2005-000934-19

Identifier Type: -

Identifier Source: secondary_id

2005-130

Identifier Type: -

Identifier Source: org_study_id