Intravenous Immunoglobulins for Post-Polio Syndrome

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona (Other)

Overall Status

Completed

CT.gov ID

NCT01537575

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-polio Syndrome	Biological: intravenous immunoglobulins Biological: Saline solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: saline solution	Biological: Saline solution Placebo
Experimental: intravenous immunoglobulins	Biological: intravenous immunoglobulins One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days

Arm

Intervention/Treatment

Placebo Comparator: saline solution

Biological: Saline solution

Placebo

Experimental: intravenous immunoglobulins

Biological: intravenous immunoglobulins

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

Outcome Measures

Primary Outcome Measures

SF-36 physical component [Baseline; 2 and 4 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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