Post Polio Syndrome, PPS Clinical Trial
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
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 Rationale:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment