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Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Information source: Haukeland University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Polio Syndrome

Intervention: IvIg (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Haukeland University Hospital

Official(s) and/or principal investigator(s):
Elisabeth Farbu, MD, PhD, Study Chair, Affiliation: Stavanger University Hospital, Stavanger, Norway

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.

Clinical Details

Official title: Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Pain after three months

Fatigue after 3 months

Muscle strength after 3 months

Secondary outcome: Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum

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.

Eligibility

Minimum age: N/A. Maximum age: 75 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: August 2003
Ending date: July 2004
Last updated: December 12, 2005

Page last updated: June 20, 2008

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