Multifocal Motor Neuropathy
Conditions
Keywords
multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin
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.
Interventions
Individually dosed, given twice a week.
DRUGIntravenous immunoglobulin
Individual dose and frequency
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
Exclusion criteria
* Other severe medical conditions * Pregnancy and lactation * Anti-coagulation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Isokinetic muscle strength at the three most affected muscle groups. | At the end of each arm of the crossover study |
Secondary
| Measure | Time frame |
|---|---|
| 9-hole peg test, | At the end of each treatment arm of the crossover study |
| 10m walking, | At the end of each treatment arm of the crossover study |
| Medical research council score (MRC-score), | At the end of each treatment arm of the crossover study |
| SF-36 | At the end of each treatment arm of the crossover study |
| Adverse effects | During each treatment arm of the crossover study |
| Nerve conduction parameters, | At the end of each treatment arm of the crossover study |
Countries
Denmark
Outcome results
None listed