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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-number: 2005-000934-19 |
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The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy
NB. ONLY RECRUITING FROM DENMARK
Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance patients require lifelong treatment. Hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. However patients with MMN have not previously been treated with subcutaneous immunoglobulin.
Hypothesis:
Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience.
Primary endpoint:
Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)
Secondary endpoint:
Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction parameters, SF-36.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subcutaneous Ig given twice a week. |
|
| 2 | Active Comparator | Intravenous Ig |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous immunoglobulin | Drug | Individually dosed, given twice a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Isokinetic muscle strength at the three most affected muscle groups. | At the end of each arm of the crossover study |
| Measure | Description | Time Frame |
|---|---|---|
| Medical research council score (MRC-score), | At the end of each treatment arm of the crossover study | |
| 9-hole peg test, | At the end of each treatment arm of the crossover study | |
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Inclusion Criteria:
- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Andersen, MD, DMSc | Aarhus University Hospital | Principal Investigator |
| Johannes Jakobsen, Professor | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Department of Neyrology | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19236457 | Derived | Harbo T, Andersen H, Hess A, Hansen K, Sindrup SH, Jakobsen J. Subcutaneous versus intravenous immunoglobulin in multifocal motor neuropathy: a randomized, single-blinded cross-over trial. Eur J Neurol. 2009 May;16(5):631-8. doi: 10.1111/j.1468-1331.2009.02568.x. Epub 2009 Feb 19. |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Intravenous immunoglobulin | Drug | Individual dose and frequency |
|
|
| 10m walking, |
| At the end of each treatment arm of the crossover study |
| Nerve conduction parameters, | At the end of each treatment arm of the crossover study |
| SF-36 | At the end of each treatment arm of the crossover study |
| Adverse effects | During each treatment arm of the crossover study |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |