Table 5.
Comparison of North American with European Prospective Study
Variable | North American Study | European Study |
---|---|---|
| ||
Study Design | Prospective study of 175 subjects seen every 6 months for 5 years by 12 North American centers | Prospective study of 141 subjects evaluated every 6 months for 2 years by 15 European centers |
| ||
Subjects | Probable MSA-P and MSA-C | Possible and probable MSA-P and MSA-C |
| ||
Study Dates | Enrollment: Dec 2003 – May 2008. Last 60 month follow up May 2010 | Jan 2003 to July 2004 |
| ||
Evaluated Variables | Defined minimal dataset and disease specific instruments (includes UMSARS I, II; COMPASS) | Same variables |
| ||
Kaplan-Meier survival | Median 9.8 years; MSA-P=MSA-C from symptom onset to death | Median 9.8 years; MSA-P had shorter survival from baseline to death |
| ||
K-M Predictors | Severe symptomatic autonomic failure at diagnosis associated with worse prognosis (by 2.4 years) | MSA-P has shorter survival than MSA-C from baseline to death |
| ||
Rate of Progression | UMSARS I: | UMSARS I: yr 1, 6.5 (0.5/month); yr 2, 2.9 (0.2/month); |
Baseline to 12 months, 0.3/month | UMSARS II: yr 1, 8.2 (0.7/month); yr 2, 5.0 (0.4/month) | |
12 to 24 months, 0.3/month | ||
UMSARS II: | ||
Baseline to 12 months, 0.5/month | ||
12 to 24 months, 0.3/month | ||
| ||
Clinical Trial implications | Probable MSA represents late stage (plateau stage) with modest rate of change | Possible and early MSA is associated with greater rate of change |
| ||
Autopsy Confirmation | 16/16 (100%) | 2/2 (100%) |
| ||
Funding Source | NINDS (NS4 4233) | European Union; Oesterreichische Nationalbank and Austrian Science Fund |