Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
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|ClinicalTrials.gov Identifier: NCT00231439|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 13, 2005
|Condition or disease||Intervention/treatment||Phase|
|Post-Polio Syndrome||Drug: IvIg||Phase 2 Phase 3|
Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years after the attack of acute polio. This leads to increased disability, and up to now only supportive therapy is available.
Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units. New data report an increased level of inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment will be investigated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)|
|Study Start Date :||August 2003|
|Estimated Study Completion Date :||July 2004|
- Pain after three months
- Fatigue after 3 months
- Muscle strength after 3 months
- Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231439
|Study Chair:||Elisabeth Farbu, MD, PhD||Stavanger University Hospital, Stavanger, Norway|