Intravenous Immunoglobulins for Post-Polio Syndrome

Condition(s) targeted: Post-polio Syndrome

Intervention: intravenous immunoglobulins (Biological); Saline solution (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Azienda Ospedaliera Universitaria Integrata Verona

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.

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

Primary outcome: SF-36 physical component

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Starting date: January 2008
Last updated: February 23, 2012