Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Post-Polio Syndrome Clinical Trial

Official title:

Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231439
• Other study ID #: HUS1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 30, 2005
• Last updated: December 12, 2005
• Start date: August 2003
• Est. completion date: July 2004

Study information

• Verified date: July 2003
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 75 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Polio Syndrome
• Postpoliomyelitis Syndrome

Intervention

Drug:
• IvIg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after three months
Primary	Fatigue after 3 months
Primary	Muscle strength after 3 months
Secondary	Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum