Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

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.

Study Overview

• Status: Completed
• Conditions: Post-Polio Syndrome
• Intervention / Treatment: Drug: IvIg

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.

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain after three months
Fatigue after 3 months
Muscle strength after 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Chair: Elisabeth Farbu, MD, PhD, Stavanger University hospital, Stavanger, Norway

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion: December 7, 2022
• Study Completion: July 1, 2004

Study Registration Dates

• First Submitted: September 30, 2005
• First Submitted That Met QC Criteria: September 30, 2005
• First Posted (Estimate): October 4, 2005

Study Record Updates

• Last Update Posted (Estimate): December 13, 2005
• Last Update Submitted That Met QC Criteria: December 12, 2005
• Last Verified: July 1, 2003

More Information

Terms related to this study

• Keywords: Post-polio syndrome; IvIg
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Poliomyelitis; Syndrome; Postpoliomyelitis Syndrome
• Other Study ID Numbers: HUS1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No