Intravenous or subcutaneous immunoglobulin therapy, multifocal motor neuropathy Nervous System Diseases Motor neuron disease
Conditions
Interventions
Patients already treated with (different) intravenous immunoglobulin will switch to weekly subcutaneous immunoglobulin (Gammaquin, Sanquin, registered in the Netherlands under RVG 16941). This treatme
Sponsors
Academic Medical Centre (AMC) (The Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult patients (greater than 18 years) with signs and symptoms consistent with MMN that fulfill the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria for definite MMN and are being treated with IVIg for at least six months at regular intervals of at most six weeks 2. Patients have to have stable disease for at least six months before inclusion
Exclusion criteria
Exclusion criteria: 1. Use of drugs which are known to cause motor neuropathy 2. Patient and/or partner is/are unable to administer SCIg at home 3. Other diseases known to cause neuropathy or to reduce mobility 4. Diseases known to lead to severe handicap or death at short notice 5. A known selective Immunoglobulin A (IgA) deficiency with anti-IgA antibodies 6. Refusal to give informed consent or withdrawal of previously given permission 7. Legally incompetent adult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is maintaining the muscle strength after switching to subcutaneous immunoglobulin measured according to the Medical Research Council scale (MRC score). The MRC score will be measured during baseline visits (between two consecutive intravenous immunoglobulin treatment). After the switch to subcutaneous immunoglobulin MRC score is determined at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Grip strength, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months 2. Functional dexterity test, measured at 3 months and at 6 months 3. Amsterdam Linear Disability Scale (ALDS), measured at 3 months and at 6 months 4. Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale, measured at 3 months and at 6 months 5. 36-item Short Form health survey (SF-36), measured at 3 months and at 6 months 6. Modified Life Quality index, measured at 3 months and at 6 months 7. Any adverse event or reaction, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months 8. Immunoglobulin G (IgG) and IgG subclass peak and trough levels, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months | — |
Countries
Netherlands
Outcome results
None listed