Summary:
This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in subjects with post polio syndrome (PPS).
The main purpose of this study is 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 2 Minutes Walk Distance (2MWD) test.
The study will consist 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).
Inclusion Criteria:
- Subjects with Body Mass Index less than 35 kg/m^2.
- Subjects meet March-of-Dimes clinical criteria for diagnosis of PPS.
- Subjects who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
- Subjects who have at least 2 newly weakened muscle groups due to PPS (as defined by medical history), with at least 1 of them in a lower extremity, and having an Medical Research Council (MRC) scale score greater than 3 at the MMT performed by the independent assessor at the Screening Visit (SV).
- Female of child-bearing potential must have a negative test for pregnancy.
- Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability.
- Subjects who are able to walk a 2MWD of at least 50 meters at the SV and Enrollment Visit/Infusion Visit 1 (EV/IV1)
- Subjects who are able to walk a consistent baseline 2 MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%.
Exclusion Criteria:
- Subjects have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years.
- Subjects who are not ambulatory (wheelchair-bound individuals).
Qualified Participants May Receive:
Compensation for time and travel, complimentary lunches. Free study-related medication and treatments.