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Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Phase 2
Completed
Conditions
Post-Polio Syndrome
Registration Number
NCT00231439
Lead Sponsor
Haukeland University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability -

Exclusion Criteria

Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pain after three months
Fatigue after 3 months
Muscle strength after 3 months
Secondary Outcome Measures
NameTimeMethod
Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
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