Intravenous Immunoglobulins for Post-Polio Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona

ClinicalTrials.gov Identifier:

NCT01537575

First received: February 17, 2012

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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: Myelitis Poliomyelitis Post Polio Syndrome

U.S. FDA Resources

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

Primary Outcome Measures:

SF-36 physical component [ Time Frame: Baseline; 2 and 4 months after treatment ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


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
Study First Received:	February 17, 2012
Last Updated:	February 23, 2012
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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