Intravenous Immunoglobulins for Post-Polio Syndrome

Post-polio Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537575
• Other study ID #: EUDRACT-200700-3559-35
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2012
• Last updated: February 23, 2012
• Start date: January 2008

Study information

• Verified date: February 2012
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-polio Syndrome
• Postpoliomyelitis Syndrome

Intervention

Biological:
• intravenous immunoglobulins
One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
• Saline solution
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 physical component		Baseline; 2 and 4 months after treatment	No