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Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Primary Purpose

Multifocal Motor Neuropathy

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Subcutaneous immunoglobulin

Intravenous immunoglobulin

About this trial

This is an interventional treatment trial for Multifocal Motor Neuropathy focused on measuring multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Aarhus University Hospital, Department of Neyrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Subcutaneous Ig given twice a week.

Intravenous Ig

Outcomes

Primary Outcome Measures

Isokinetic muscle strength at the three most affected muscle groups.

Secondary Outcome Measures

Medical research council score (MRC-score),

9-hole peg test,

10m walking,

Nerve conduction parameters,

SF-36

Adverse effects

Full Information

NCT ID

NCT00268788

First Posted

December 21, 2005

Last Updated

February 19, 2008

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT00268788

Brief Title

Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multifocal Motor Neuropathy

Keywords

multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Subcutaneous Ig given twice a week.

Arm Title

Arm Type

Active Comparator

Arm Description

Intravenous Ig

Intervention Type

Drug

Intervention Name(s)

Subcutaneous immunoglobulin

Other Intervention Name(s)

Subcuvia

Intervention Description

Individually dosed, given twice a week.

Intervention Type

Drug

Intervention Name(s)

Intravenous immunoglobulin

Other Intervention Name(s)

Endobulin

Intervention Description

Individual dose and frequency

Primary Outcome Measure Information:

Title

Isokinetic muscle strength at the three most affected muscle groups.

Time Frame

At the end of each arm of the crossover study

Secondary Outcome Measure Information:

Title

Medical research council score (MRC-score),

Time Frame