Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS) (NCT00160082) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
Sweden124 participantsStarted 2001-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
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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.
Exclusion criteria
✕. Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose).
✕. Selective IgA deficiency.
✕. Inability to walk with walking aids.
✕
What they're measuring
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Primary endpoints:
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Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.
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Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.
. Any active malignancy, history of active malignancy or treatment for malignancy during the last three years.
✕. Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS.
✕. Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded).
✕. Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit.
✕. Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit.