Clinical Trial: Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)
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 Summary:
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.
Sponsor: Haukeland University Hospital
Current Primary Outcome:
- Pain after three months
- Fatigue after 3 months
- Muscle strength after 3 months
Original Primary Outcome: Same as current
Current Secondary Outcome: Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
Original Secondary Outcome: Same as current
Information By: Haukeland University Hospital
Dates:
Date Received: September 30, 2005
Date Started: August 2003
Date Completion: July 2004
Last Updated: December 12, 2005
Last Verified: July 2003
