Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Multifocal Motor Neuropathy

Treatments: Drug: Subcutaneous immunoglobulin; Drug: Intravenous immunoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00268788

2005-130

EudraCT-number: 2005-000934-19

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

1

Active Comparator group

Description:

Subcutaneous Ig given twice a week.

Treatment:

Drug: Subcutaneous immunoglobulin

2

Active Comparator group

Description:

Intravenous Ig

Treatment:

Drug: Intravenous immunoglobulin