CompletedPhase 3

Intravenous Immunoglobulins for Post-Polio Syndrome

50 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

SF-36 physical component

Timeframe: Baseline; 2 and 4 months after treatment

Trial details

NCT IDNCT01537575

SponsorAzienda Ospedaliera Universitaria Integrata Verona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Post-polio Syndrome trials