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Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

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ClinicalTrials.gov Identifier: NCT00268788
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : February 21, 2008
Sponsor:
Information provided by:
University of Aarhus

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


Condition or disease Intervention/treatment Phase
Multifocal Motor Neuropathy Drug: Subcutaneous immunoglobulin Drug: Intravenous immunoglobulin Phase 2

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
Study Start Date : August 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Isokinetic muscle strength at the three most affected muscle groups. [ Time Frame: At the end of each arm of the crossover study ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008

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

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