Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
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
|Multifocal Motor Neuropathy||Drug: Subcutaneous immunoglobulin Drug: Intravenous immunoglobulin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy|
- Isokinetic muscle strength at the three most affected muscle groups. [ Time Frame: At the end of each arm of the crossover study ]
- Medical research council score (MRC-score), [ Time Frame: At the end of each treatment arm of the crossover study ]
- 9-hole peg test, [ Time Frame: At the end of each treatment arm of the crossover study ]
- 10m walking, [ Time Frame: At the end of each treatment arm of the crossover study ]
- Nerve conduction parameters, [ Time Frame: At the end of each treatment arm of the crossover study ]
- SF-36 [ Time Frame: At the end of each treatment arm of the crossover study ]
- Adverse effects [ Time Frame: During each treatment arm of the crossover study ]
|Study Start Date:||August 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Subcutaneous Ig given twice a week.
Drug: Subcutaneous immunoglobulin
Individually dosed, given twice a week.
Other Name: Subcuvia
Active Comparator: 2
Drug: Intravenous immunoglobulin
Individual dose and frequency
Other Name: Endobulin
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.
Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience.
Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)
Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction parameters, SF-36.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268788
|Aarhus University Hospital, Department of Neyrology|
|Principal Investigator:||Henning Andersen, MD, DMSc||Aarhus University Hospital, Aarhus, Denmark|
|Study Chair:||Johannes Jakobsen, Professor||Aarhus University Hospital|