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Intravenous Immunoglobulins for Post-Polio Syndrome

This study has been completed.
ClinicalTrials.gov Identifier:
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
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:

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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:
Postpoliomyelitis Syndrome
Pathologic Processes
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs