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Intravenous Immunoglobulins for Post-Polio Syndrome
This study has been completed.
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Polio and Post-Polio Syndrome
Drug Information available for:
Rhophylac
U.S. FDA Resources
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
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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No Contacts or Locations Provided
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 |
| Study First Received: | February 17, 2012 |
| Last Updated: | February 23, 2012 |
Additional relevant MeSH terms:
|
Syndrome Postpoliomyelitis Syndrome Disease Pathologic Processes Poliomyelitis Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Myelitis |
Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neurodegenerative Diseases Neuromuscular Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017