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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.
Full description
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.
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Inclusion criteria
Male or female subjects ≥18 to ≤75 years of age.
Post-polio syndrome according to Halstead and Gawne:
Confirmed polio by EMG in the lower extremities in at least two of the following major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two affected muscle groups in the same extremity were accepted).
Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability.
A muscle that had deteriorated within the last five years, and had 20-75 % of the muscle strength compared to age matched normal population when measured by a dynamometer or an electronic grip force sensor (GRIPPIT).
Stable weight (defined as weight change <7 kg) during the last five years.
Body Mass Index (BMI) £ 29 kg/m2.
Subjects capable to understand given information and had signed the Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits.
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Data sourced from clinicaltrials.gov
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