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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:

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

ClinicalTrials.gov processed this record on May 16, 2013