Table 3.
Progression of ALSFRS-R and FVC% in treated with ALCAR 3 g/day and not treated
| Group | Time | ALSFRS-R | FVC | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Estimatea | 95% lower CL | 95% upper CL | p value | Estimatea | 95% lower CL | 95% upper CL | p value | ||
| Treated with ALCAR 3 g/day | Month 0 | 42.2 | 39.5 | 44.8 | 98.6 | 88.5 | 108.7 | ||
| Month 4 | 37.1 | 34.2 | 39.9 | 88.2 | 78.0 | 98.4 | |||
| Month 8 | 32.0 | 28.5 | 35.4 | 77.8 | 66.5 | 89.2 | |||
| Month 12 | 26.9 | 22.6 | 31.2 | 67.4 | 54.2 | 80.7 | |||
| Month 18 | 19.2 | 13.4 | 25.0 | 51.8 | 34.8 | 68.8 | |||
| Month 24 | 11.5 | 4.2 | 18.9 | 36.2 | 14.9 | 57.6 | |||
| Slope | − 1.3 | − 1.6 | − 1.0 | < 0.0001 | − 2.6 | − 3.4 | − 1.8 | < 0.0001 | |
| Not treated | Month 0 | 43.4 | 41.0 | 45.8 | 101.4 | 92.5 | 110.2 | ||
| Month 4 | 38.2 | 35.6 | 40.7 | 88.2 | 79.3 | 97.2 | |||
| Month 8 | 33.0 | 29.7 | 36.2 | 75.1 | 64.7 | 85.5 | |||
| Month 12 | 27.7 | 23.6 | 31.9 | 61.9 | 49.2 | 74.7 | |||
| Month 18 | 19.9 | 14.3 | 25.6 | 42.2 | 25.2 | 59.3 | |||
| Month 24 | 12.1 | 4.8 | 19.4 | 22.5 | 0.6 | 44.4 | |||
| Slope | − 1.3 | − 1.6 | − 1.0 | < 0.0001 | − 3.3 | − 4.2 | − 2.4 | < 0.0001 | |
| Treated with ALCAR 3 g/day vs. not treated (difference) | Month 0 | − 1.2 | − 2.9 | 0.5 | − 2.8 | − 9.7 | 4.1 | ||
| Month 4 | − 1.1 | − 3.4 | 1.1 | 0.0 | − 7.3 | 7.3 | |||
| Month 8 | − 1.0 | − 4.6 | 2.5 | 2.7 | − 7.6 | 13.1 | |||
| Month 12 | − 0.9 | − 6.0 | 4.2 | 5.5 | − 9.0 | 20.0 | |||
| Month 18 | − 0.7 | − 8.2 | 6.8 | 9.6 | − 11.8 | 31.0 | |||
| Month 24 | − 0.5 | − 10.5 | 9.4 | 13.7 | − 14.8 | 42.2 | |||
| Slope | 0.0 | − 0.4 | 0.4 | 0.8910 | 0.7 | − 0.6 | 1.9 | 0.2747 | |
ALCAR acetyl-l-carnitine, FVC forced vital capacity, ALSFRS-R amyotrophic lateral sclerosis functional rating scale-revised, CL confidence limit
aMatched by age (± 5 years), sex, disease duration (± 3 years), site of onset; adjusted by riluzole use, EL Escorial category, progression rate category