Intravenous versus Subcutaneous Immunoglobuline therapy in Multifocal motor neuropathy

Phase 4

Conditions: motor neuropathy
nerve damage
10034606

Registration Number: NL-OMON31197

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is defined as the proportion of patients who deteriorate<br /><br>more than 1 point in the MRC (Medical Research Council) sum score during SCIg<br /><br>treatment as compared with IVIg treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters<br /><br><br /><br>1. grip strength<br /><br>2. functional dexterity test<br /><br>3. ALDS<br /><br>4. INCAT disability scale<br /><br>5. SF-36<br /><br>6. Modified Life Quality index<br /><br>7. any adverse event or reaction<br /><br>8. IgG and IgG subclass peak and trough levels</p><br>