| - candidate number | 2585 |
| - NTR Number | NTR974 |
| - ISRCTN | ISRCTN66618743 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 15-mei-2007 |
| - Secondary IDs | |
| - Public Title | Intravenous versus subcutaneous immunoglobuline therapy in multifocal motor neuropathy |
| - Scientific Title | Intravenous versus subcutaneous immunoglobuline therapy in patients with multifocal motor neuropathy in regard of muscle strength and disability |
| - ACRONYM | ISIM |
| - hypothesis | Subcutaneous immunoglobuline therapy is as effective as intravenous immunoglobuline therapy in maintaining muscle strength in patients with multifocal motor neuropathy |
| - Healt Condition(s) or Problem(s) studied | Subcutaneous immunoglobuline therapy , Multifocal motor neuropathy, Intravenous immunoglobulins |
| - 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 | 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 |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Crossover |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jun-2007 |
| - planned closingdate | 1-jun-2009 |
| - Target number of participants | 10 |
| - Interventions | Patients already treated with (different) intravenous immunoglobuline will switch to weekly subcutaneous immunoglobuline (Gammaquin, Sanquin, registered in the Netherlands under RVG 16941). This treatment will be continued for 6 months. After reaching the end of the study patients are allowed to choose between both treatments which they will continue. |
| - Primary outcome | 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 outcome | 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 |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | F. Eftimov |
| - CONTACT for SCIENTIFIC QUERIES | I.N. Schaik, van |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Neurology |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Department of Neurology, Sanquin Blood Supply |
| - Publications | The writing commettee will consist of F. Eftimov, I.N. van Schaik, R. de Haan and M. Vermeulen. |
| - Brief summary | Multifocal motor neuropathy (MMN) is a rare immune mediated disorder characterized by slowly progressive, asymmetric, predominantly distal weakness of one or more limbs without sensory loss. Intravenous immunoglobuline (IVIg) is the first line treatment when disability is sufficiently severe to warrant treatment. An alternative route of immunoglobulin administration is subcutaneous immunoglobulin (SCIg), used in patients with immuno-deficiency syndromes. Our hypothesis is that SCIg therapy is as effective as IVIg therapy in maintaining muscle strength in patients with MMN. Patiens using IVIg will switch to SCIg and will be followed for at least 6 months in which muscle stregth, disability, side effects and immunoglobuline serum levels will be assessed. |
| - Main changes (audit trail) | |
| - RECORD | 15-mei-2007 - 3-jul-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl