Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268788
Status:
COMPLETED
Last Update Posted:
2008-02-21
First Post:
2005-12-21
Brief Title:
Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
NB ONLY RECRUITING FROM DENMARK
Detailed Description:
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 iv 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 iv
Secondary endpoint
Medical research council score MRC-score 9-hole peg test 10m walking Nerve conduction parameters SF-36
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 iv
Secondary endpoint
Medical research council score MRC-score 9-hole peg test 10m walking Nerve conduction parameters SF-36
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-number 2005-000934-19 | None | None | None |