Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multifocal Motor Neuropathy
Intervention: Subcutaneous immunoglobulin (Drug); Intravenous immunoglobulin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Henning Andersen, MD, DMSc, Principal Investigator, Affiliation: Aarhus University Hospital, Aarhus, Denmark
Johannes Jakobsen, Professor, Study Chair, Affiliation: Aarhus University Hospital
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
Clinical Details
Official title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Isokinetic muscle strength at the three most affected muscle groups.
Secondary outcome: Medical research council score (MRC-score),9-hole peg test, 10m walking, Nerve conduction parameters, SF-36 Adverse effects
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Aarhus University Hospital, Department of Neyrology, Aarhus, Denmark
Additional Information
Starting date: August 2005
Last updated: February 19, 2008
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