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

February 17, 2012
February 23, 2012
January 2008
December 2009   (final data collection date for primary outcome measure)
SF-36 physical component [ Time Frame: Baseline; 2 and 4 months after treatment ] [ Designated as safety issue: No ]
SF-36 physical component [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01537575 on ClinicalTrials.gov Archive Site
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Intravenous Immunoglobulins for Post-Polio Syndrome
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Post-polio Syndrome
  • Biological: intravenous immunoglobulins
    One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
  • Biological: Saline solution
    Placebo
  • Placebo Comparator: saline solution
    Intervention: Biological: Saline solution
  • Experimental: intravenous immunoglobulins
    Intervention: Biological: intravenous immunoglobulins
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01537575
EUDRACT-200700-3559-35
No
Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera Universitaria Integrata Verona
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Azienda Ospedaliera Universitaria Integrata Verona
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP