Intravenous versus subcutaneous immunoglobuline therapy in multifocal motor neuropathy

Intravenous versus subcutaneous immunoglobuline therapy in patients with multifocal motor neuropathy in regard of muscle strength and disability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21709

Enrollment

Registered

2007-05-15

Start date

2007-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subcutaneous immunoglobuline therapy Multifocal motor neuropathy Intravenous immunoglobuline therapy Dutch: subcutane immunoglobuline Intraveneus immunoglobuline Multifocale motorische neuropathy

Interventions

Patients already treated with (different) intravenous immunoglobuline will switch to weekly subcutaneous immunoglobuline (Gammaquin, Sanquin, registered in the Netherlands under RVG 16941). This treat

Eligibility

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: 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 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 immunoglobuline measured according to the Medical Research Counsil scale (MRC score). The MRC score will be measured during baseline visits (between 2 consecutive intravenous immunoglobuline treatment). After the switch to subcutaneous immunoglobuline MRC score is determined at 1, 2, 3, 4, 6 weeks and 3 4 and 6 months.	—

Measure

Time frame

Primary outcome is maintaining the muscle strength after switching to subcutaneous immunoglobuline measured according to the Medical Research Counsil scale (MRC score). The MRC score will be measured during baseline visits (between 2 consecutive intravenous immunoglobuline treatment). After the switch to subcutaneous immunoglobuline MRC score is determined at 1, 2, 3, 4, 6 weeks and 3 4 and 6 months.

—

Secondary

Measure	Time frame
1. Grip strength 2. Functional dexterity test 3. Amsterdam Linear disability scale (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	—

Contacts

Public ContactF. Eftimov

Academical Medical Centre Department of Neurology

f.eftimov@amc.uva.nl+31 20-5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)