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Intravenous Immunoglobulins for Post-Polio Syndrome

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01537575

First Posted: February 23, 2012

Last Update Posted: February 27, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona

Purpose

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	Intervention	Phase
Post-polio Syndrome	Biological: intravenous immunoglobulins Biological: Saline solution	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Polio and Post-Polio Syndrome

Drug Information available for: Rhophylac

Genetic and Rare Diseases Information Center resources: Poliomyelitis Post Polio Syndrome Myelitis

U.S. FDA Resources

Further study details as provided by Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona:

Primary Outcome Measures:

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


Enrollment:	50
Study Start Date:	January 2008
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information


Responsible Party:	Laura Bertolasi, Head of the Neurophysiology Unit, Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:	NCT01537575 History of Changes
Other Study ID Numbers:	EUDRACT-200700-3559-35
First Submitted:	February 17, 2012
First Posted:	February 23, 2012
Last Update Posted:	February 27, 2012
Last Verified:	February 2012

Additional relevant MeSH terms:


Syndrome Postpoliomyelitis Syndrome Disease Pathologic Processes Poliomyelitis Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Myelitis	Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neurodegenerative Diseases Neuromuscular Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs

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