Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231439
Status:
COMPLETED
Last Update Posted:
2005-12-13
First Post:
2005-09-30
Brief Title:
Post-Poliosyndrome Treated With Intravenous Immunoglobulin IvIg
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Post-Polio Syndrome Treated With Intravenous Immunoglobulin IvIg
Status:
COMPLETED
Status Verified Date:
2003-07
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:
Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness fatigue and pain experienced by patients with post-polio syndrome Intravenousimmunoglobulin IvIg reduces this inflammation The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome
Detailed Description:
Post-polio syndrome PPS is characterised by new muscle weakness pain and fatigue several years after the attack of acute polio This leads to increased disability and up to now only supportive therapy is available
Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units New data report an increased level of inflammatory cytokines in the cerebrospinal fluid CSF Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS In addition levels of cytokines in CSF and serum before and after treatment will be investigated
Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units New data report an increased level of inflammatory cytokines in the cerebrospinal fluid CSF Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS In addition levels of cytokines in CSF and serum before and after treatment will be investigated
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