Intravenous Immunoglobulins for Post-Polio Syndrome
Phase 3
Completed
- Conditions
- Post-polio Syndrome
- Interventions
- Biological: Saline solutionBiological: intravenous immunoglobulins
- Registration Number
- NCT01537575
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline solution Saline solution - intravenous immunoglobulins intravenous immunoglobulins -
- Primary Outcome Measures
Name Time Method SF-36 physical component Baseline; 2 and 4 months after treatment
- Secondary Outcome Measures
Name Time Method