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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR974 |
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Date of registration:
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15/05/2007 |
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Primary sponsor: |
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Public title:
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Intravenous versus subcutaneous immunoglobuline therapy in multifocal motor neuropathy
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Scientific title:
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Intravenous versus subcutaneous immunoglobuline therapy in patients with multifocal motor neuropathy in regard of muscle strength and disability - ISIM |
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Date of first enrolment:
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1/6/2007 |
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Target sample size:
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10 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=974 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Crossover; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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F.
Eftimov |
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Address:
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Academical Medical Centre
Department of Neurology, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 20-5669111 |
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Email:
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f.eftimov@amc.uva.nl |
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Affiliation:
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Name:
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I.N.
Schaik, van |
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Address:
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Academical Medical Centre,
Department of Neurology
, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 20-5669111 |
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Email:
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i.n.vanschaik@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Subcutaneous immunoglobuline therapy , Multifocal motor neuropathy, Intravenous immunoglobulins
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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ISRCTN66618743
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Neurology, Sanquin Blood Supply
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