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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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