Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Pain after three monthsFatigue 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
Last updated: December 12, 2005
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