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Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00231439
Enrollment
40
Registered
2005-10-04
Start date
2003-08-31
Completion date
2004-07-31
Last updated
2005-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Polio Syndrome

Keywords

Post-polio syndrome, 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 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.

Interventions

DRUGIvIg

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
0 Years to 75 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pain after three months
Fatigue after 3 months
Muscle strength after 3 months

Secondary

MeasureTime frame
Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026