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Completed

NCT Number: NCT00268788

Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

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

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Key information

Conditions

Multifocal Motor Neuropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Department of Neyrology

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

subcutaneous immunoglobulin

Drug

Individually dosed, given twice a week.

Other names: Subcuvia

intravenous immunoglobulin

Drug

Individual dose and frequency

Other names: Endobulin

Primary outcomes

  1. Isokinetic muscle strength at the three most affected muscle groups.

    Time frame: At the end of each arm of the crossover study

Secondary outcomes

  1. Medical research council score (MRC-score),

    Time frame: At the end of each treatment arm of the crossover study

  2. 9-hole peg test,

    Time frame: At the end of each treatment arm of the crossover study

  3. 10m walking,

    Time frame: At the end of each treatment arm of the crossover study

  4. Nerve conduction parameters,

    Time frame: At the end of each treatment arm of the crossover study

  5. SF-36

    Time frame: At the end of each treatment arm of the crossover study

  6. Adverse effects

    Time frame: During each treatment arm of the crossover study

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2005
Registry last updated
Feb 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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