Table of ContentsPPT Slide SygenÆ (monosialotetrahexosylganglioside GM-1) SygenÆ (GM-1 Ganglioside) Maryland GM-1 Acute SCI Trial SygenÆ (GM-1) Acute SCI Study Design SygenÆ (GM-1) Acute SCI Study Design (contíd) SygenÆ (GM-1) Acute SCI Study Operational Aspects ASIA Impairment Scale (AIS) (Pre-Treatment Only) Modified Benzel Classification (Weeks 4, 8, 16, 26, and 52 F/U) Modified Benzel Classification (cont.) (Weeks 4, 8, 16, 26, and 52 F/U) Major Improvement Criterion: AIS/Benzel Neurologic Improvement Pre-planned Primary Outcome Measures Pre-planned Secondary Outcome Measures and Analyses SygenÆ (GM-1) Acute SCI Study Size and Duration Enrollment in the SygenÆ (GM-1) Acute SCI Study Patient Accounting Analysis Group (n=760) Safety Data Summary Survival by Treatment Group (47 Deaths in 797 Patients) Population Characteristics Week 26 Major AIS/Benzel Improvers by Baseline AIS Strata and Level Week 26 Benzel Outcome Grade by Baseline AIS Strata Week 26 Major AIS/Benzel Improvers by Baseline AIS Strata and MPSS Timing Patient Enrollment by Treatment Group and Strata: Age, Level, Baseline AIS Major (2 Grade AIS/Benzel) Improvers by Visit Baseline A Baseline B Baseline C+D Operated (n=521) vs. Non-Operated (n=140) Patients (Placebo and Sygen 100mg) Operated vs. Non-Operated by Treatment Group Summary of Findings to Date Summary of Findings to Date (cont.) Conclusions SygenÆ (GM-1) Principal Investigators and Centers SygenÆ (GM-1) Principal Investigators and Centers (cont.) |
Author: Fred H. Geisler |