Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00268788
First received: December 21, 2005
Last updated: February 19, 2008
Last verified: February 2008
  Purpose

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


Condition Intervention Phase
Multifocal Motor Neuropathy
Drug: Subcutaneous immunoglobulin
Drug: Intravenous immunoglobulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Isokinetic muscle strength at the three most affected muscle groups. [ Time Frame: At the end of each arm of the crossover study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical research council score (MRC-score), [ Time Frame: At the end of each treatment arm of the crossover study ] [ Designated as safety issue: No ]
  • 9-hole peg test, [ Time Frame: At the end of each treatment arm of the crossover study ] [ Designated as safety issue: No ]
  • 10m walking, [ Time Frame: At the end of each treatment arm of the crossover study ] [ Designated as safety issue: No ]
  • Nerve conduction parameters, [ Time Frame: At the end of each treatment arm of the crossover study ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: At the end of each treatment arm of the crossover study ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: During each treatment arm of the crossover study ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subcutaneous Ig given twice a week.
Drug: Subcutaneous immunoglobulin
Individually dosed, given twice a week.
Other Name: Subcuvia
Active Comparator: 2
Intravenous Ig
Drug: Intravenous immunoglobulin
Individual dose and frequency
Other Name: Endobulin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268788

Locations
Denmark
Aarhus University Hospital, Department of Neyrology
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Henning Andersen, MD, DMSc Aarhus University Hospital, Aarhus, Denmark
Study Chair: Johannes Jakobsen, Professor Aarhus University Hospital
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Harbo, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00268788     History of Changes
Other Study ID Numbers: 2005-130, EudraCT-number: 2005-000934-19
Study First Received: December 21, 2005
Last Updated: February 19, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
multifocal motor neuropathy
subcutaneous
IVIG
gammaglobulin

Additional relevant MeSH terms:
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014