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Completed

NCT Number: NCT01537575

Intravenous Immunoglobulins for Post-Polio Syndrome

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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Key information

Conditions

Post-Polio Syndrome Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Myelitis Nervous System Diseases Neurodegenerative Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis Postpoliomyelitis Syndrome RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous immunoglobulins

Biological

One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days

Saline solution

Biological

Placebo

Primary outcomes

  1. SF-36 physical component

    Time frame: Baseline; 2 and 4 months after treatment

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 23, 2012
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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