Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
The primary objective was to assess the effect of Xepol compared to placebo on physical health and on muscle strength in subjects with post-polio syndrome.The secondary objective was to assess the effect of Xepol compared to placebo on functional balance, activity patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking ability, balance and safety.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS): A Randomized, Two-Arm, Parallel, Double-Blind, Multi-Centre, Placebo Controlled Study|
- Primary endpoints:
- Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.
- Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.
- Secondary endpoints:
- Functional balance was assessed by using the Timed “Up and Go” (TUG) test.
- Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE).
- Pain was assessed by a Visual Analogue Scale and by a pain drawing.
- Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
- Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire.
- Sleep was assessed using the Sleep quality scale.
- Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint.
- Walking ability was assessed by a 6 minutes walking test.
- Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method.
- Balance was assessed as postural sway velocity and the subject’s ability to voluntarily sway to various locations in space (NeuroCom Balance Master) or balance assessed by static and dynamic posturography (Chattecx® balance system)
- Adverse events
- Vital signs (blood pressure and heart rate)
- Physical examination
- Laboratory tests
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||May 2003|
In an earlier open and non-controlled study in 10 patients with PPS, Xepol was given during three days. The patients showed improvements in muscular strength and co-ordination and a decrease in pain. The aim of this study was to investigate if these findings can be confirmed in a larger, double-blind, randomised and placebo controlled study.
There are no simple clinical findings and specific laboratory changes that can be used to indicate the severity and progress of PPS. Different self-reporting questionnaires and objective measures of disability have often been used in clinical studies including SF-36 questionnaire, muscle strength measurement and walking test. The primary and secondary variables in this study were based on the clinical experience and literature reviewed.
|Sahlgrenska University Hospital|
|Huddinge University Hospital|
|Stockholm, Sweden, SE-141 86|
|Uppsala Academic Hospital|
|Principal Investigator:||Kristian Borg, MD, Prof||Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden|