This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS). The main purpose of this study was to select a dose of Flebogamma® 5% DIF and confirm the efficacy of the selected Flebogamma® 5% DIF dose by assessing physical performance, as measured by Two-Minute Walk Distance (2MWD) test. The study consisted of 2 stages, with each stage consisting of a screening period (up to 4 weeks), a treatment period (52 weeks), and a follow-up period (24 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
191
Human plasma-derived immunoglobulin
Matching placebo
Washington University
St Louis, Missouri, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Montreal Neurological Institute Clinical Research Unit, McGill University
Montreal, Quebec, Canada
Thomayerova nemocnice, Klinicko-farmakologická jednotka
Prague, Czechia
Aarhus Universitets Hospital-Neurologisk Forskning
Aarhus N, Denmark
Rigshospitalet
København Ø, Denmark
Charité Campus Mitte
Berlin, Germany
Hannover Medical School
Hanover, Germany
...and 11 more locations
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test
The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.
Time frame: Baseline to Week 52
Change From Baseline in Pain Using Visual Analogue Scale (VAS) of Pain
VAS is a participant self-reported pain scale used to evaluate the pain level in a 24 hours period. The scale consists of a 100 millimeters (mm) scale where 100 mm stands for the worst imaginable pain and zero stands for no pain. Higher scores indicate severe pain. A negative change from baseline indicates improvement. LS mean and 95% (CI) were based on MMRM method.
Time frame: Baseline to Week 52
Change From Baseline in Health-Related Quality of Life (HRQoL) Assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
HRQoL SF-36 is participant self-reported survey.It yields 8-scale profile of functional health and well-being as well as physical and mental health summary measures. It consists of the subscales:physical functioning,limitations due to physical health,body pain,general health,vitality,social functioning,emotional problems, and mental health. Each domain score ranges from 0(worst) to 100(best),higher scores reflect better functional status.PCS is a subscale score \& give broader metric of physical HRQoL.PCS score ranges from 0 to 100 and is computed such that mean score of 50 corresponds to the general US population.Based on norm-based scoring,scores above 50 is better-than-average health \& below 50 is below-average health.Higher scores represents better physical health.Positive change from baseline indicates improvement.LS mean and 95% CI were based on MMRM.
Time frame: Baseline to Week 52
Change From Baseline in Endurance Assessed by Six-Minute Walk Distance (6MWD) Test
The 6MWD was used to assess physical performance by measuring the distance that a patient can quickly walk at maximal speed on a flat, hard surface 30 m (100-ft) hallway in a period of 6 minutes. A positive change from baseline indicates improvement (i.e., a patient can walk farther). Increase from baseline in distance walked (in meters) indicated improvement. LS mean and 95% CI were based on MMRM method.
Time frame: Baseline to Week 52
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