motor neuropathy nerve damage
Conditions
Interventions
After informed consent and baseline assessments, all patients will receive
subcutaneous immunoglobuline (SCIg, Gammaquin) one week after the second IVIg
treatment. Patients shall be instructed how t
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All adult patients (??? 18 years) with signs and symptoms consistent with MMN that fulfill the EFNS/PNS criteria for definite MMN and are being treated with IVIg for at least 6 months at regular intervals of at most 6 weeks. Patients have to have stable disease for at least 6 months before inclusion.
Exclusion criteria
Exclusion criteria: Use of drugs which are known to cause motor neuropathy Patient and/or partner is/are unable to administer SCIg at home. Other diseases known to cause neuropathy or to reduce mobility Diseases known to lead to severe handicap or death at short notice A known selective IgA deficiency with anti-IgA antibodies Refusal to give informed consent or withdrawal of previously given permission Legally incompetent adult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is defined as the proportion of patients who deteriorate more than 1 point in the MRC (Medical Research Council) sum score during SCIg treatment as compared with IVIg treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters 1. grip strength 2. functional dexterity test 3. ALDS 4. INCAT disability scale 5. SF-36 6. Modified Life Quality index 7. any adverse event or reaction 8. IgG and IgG subclass peak and trough levels | — |
Countries
Netherlands
Outcome results
None listed