Intravenous Immunoglobulins for Post-Polio Syndrome

This study has been completed.
Information provided by (Responsible Party):
Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona Identifier:
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: February 2012
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:

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
Experimental: intravenous immunoglobulins Biological: intravenous immunoglobulins
One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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No Contacts or Locations Provided
  More Information

Responsible Party: Laura Bertolasi, Head of the Neurophysiology Unit, Azienda Ospedaliera Universitaria Integrata Verona 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
Enterovirus Infections
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2016