A Phase 2 interventional study of Subcutaneous immunoglobulin and Intravenous immunoglobulin in Multifocal Motor Neuropathy, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-02-21.
Sponsored by University of Aarhus · Phase 2, Interventional, and Treatment
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
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.
University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
Exclusion Criteria:
Subcutaneous Ig given twice a week.
Drug: Subcutaneous immunoglobulin
Intravenous Ig
Drug: Intravenous immunoglobulin
Individually dosed, given twice a week.
Also known as: Subcuvia
Individual dose and frequency
Also known as: Endobulin
Isokinetic muscle strength at the three most affected muscle groups.
Time frame: At the end of each arm of the crossover study
Medical research council score (MRC-score),
Time frame: 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
10m walking,
Time frame: 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
SF-36
Time frame: At the end of each treatment arm of the crossover study
Adverse effects
Time frame: During each treatment arm of the crossover study
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Immunoglobulins · Immunoglobulins, Intravenous