Intravenous Immunoglobulins for Post-Polio Syndrome

Integrated University Hospital Trust of Verona

Status and phase: Completed; Phase 3

Conditions: Post-polio Syndrome

Treatments: Biological: intravenous immunoglobulins; Biological: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01537575

EUDRACT-200700-3559-35

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

saline solution

Placebo Comparator group

Treatment:

Biological: Saline solution

intravenous immunoglobulins

Experimental group

Treatment:

Biological: intravenous immunoglobulins