Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)|
- Pain after three months
- Fatigue after 3 months
- Muscle strength after 3 months
- Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||July 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231439
|Study Chair:||Elisabeth Farbu, MD, PhD||Stavanger University Hospital, Stavanger, Norway|