Intravenous Immunoglobulins for Post-Polio Syndrome

Azienda Ospedaliera Universitaria Integrata Verona50 enrolled

Overview

Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-polio Syndrome

Interventions

intravenous immunoglobulinsBIOLOGICAL

One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days

Saline solutionBIOLOGICAL

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a history of acute poliomyelitis * increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis * a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi Exclusion Criteria: * clinically relevant systemic disease * malignancy * hypothyroidism * diabetes mellitus not fully controlled by medical therapy * medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome * conditions associated with prolonged coagulation time * serum IgA deficiency * previous allergic reaction to IVIG * body-mass index greater than 30 * immune-modulating treatments other than IVIG within the preceding 6 months

Outcomes

Primary Outcomes

SF-36 physical component

Time frame: Baseline; 2 and 4 months after treatment

Data from ClinicalTrials.gov

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