Post-Polio Syndrome Clinical Trial
Official title:
Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)
Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness, fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 75 Months |
Eligibility |
Inclusion Criteria: Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability - Exclusion Criteria: Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain after three months | |||
Primary | Fatigue after 3 months | |||
Primary | Muscle strength after 3 months | |||
Secondary | Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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