Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

February 19, 2008 updated by: University of Aarhus

A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital, Department of Neyrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subcutaneous Ig given twice a week.
Drug: Subcutaneous immunoglobulin
Individually dosed, given twice a week.
Other Names:
  • Subcuvia
Active Comparator: 2
Intravenous Ig
Drug: Intravenous immunoglobulin
Individual dose and frequency
Other Names:
  • Endobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Isokinetic muscle strength at the three most affected muscle groups.
Time Frame: At the end of each arm of the crossover study
At the end of each arm of the crossover study

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical research council score (MRC-score),
Time Frame: At the end of each treatment arm of the crossover study
At the end of each treatment arm of the crossover study
9-hole peg test,
Time Frame: At the end of each treatment arm of the crossover study
At the end of each treatment arm of the crossover study
10m walking,
Time Frame: At the end of each treatment arm of the crossover study
At the end of each treatment arm of the crossover study
Nerve conduction parameters,
Time Frame: At the end of each treatment arm of the crossover study
At the end of each treatment arm of the crossover study
SF-36
Time Frame: At the end of each treatment arm of the crossover study
At the end of each treatment arm of the crossover study
Adverse effects
Time Frame: During each treatment arm of the crossover study
During each treatment arm of the crossover study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Henning Andersen, MD, DMSc, Aarhus University Hospital, Aarhus, Denmark
  • Study Chair: Johannes Jakobsen, professor, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 21, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-130
  • EudraCT-number: 2005-000934-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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