Table 5 Fatigue outcomes of MAO-BI studies.
Studies | Study design | Participants | Study quality | Age | Disease duration | Instruments | Outcome | Effect size |
|---|---|---|---|---|---|---|---|---|
Stocchi et al. (2014)62 | Multicenter, double-blind, placebo-controlled RCT, 36 weeks | 1105 patients, early PD not requiring dopaminergic therapy | 1 | 62.2 (9.7) | 4.5 (4.6) | Parkinson’s fatigue scale | Significantly better in rasagiline 1 mg vs placebo, −0.14 ± 0.05, P < 0.01 | 0.03 |
Parkinson’s fatigue scale | Significantly better in rasagiline 2 mg vs placebo, −0.19 ± 0.05, P < 0.0001 | 0.02 | ||||||
Lim et al. (2015)23 | Multicenter, double-blind, placebo-controlled RCT, 12 weeks | 30 patients, PD with moderate to severe fatigue (FSS ≥ 4) | 1 | 68.7 (7.4) | 3 (median) | Modified fatigue impact Scale | Significantly better in rasagiline 1 mg vs placebo (12 vs 8.5 points), P = 0.003 | IC |
3 (median) | FSS | Significantly better in rasagiline 1 mg vs placebo (13 vs 3 points), P = 0.027 | IC | |||||
3 (median) | Multidimensional fatigue inventory | Significantly better in rasagiline 1 mg vs placebo (5 vs 1 points), P = 0.04 | IC | |||||
3 (median) | Objective physical and mental fatigue testing | No significant differences between rasagiline 1 mg and placebo (0 vs 0.07 points), P = 0.26 | IC | |||||
Santos García et al. (2021)25 | Multicenter, open-label, prospective study, 6 months | 50 patients, PD with high non-motor burden (NMSS ≥ 40) | 3 | 68.5 (9.1) | 6.4 (5.1) | Visual analog fatigue scale: physical | No significant change with safinamide 100 mg; baseline 4.2 ± 2.8 and post 3.6 ± 2.6, P = 0.293 | 0.19 |
Visual analog fatigue scale: mental | No significant change with safinamide 100 mg; baseline 3.1 ± 2.7 and post 2.5 ± 2.8, P = 0.118 | 0.26 | ||||||
De Micco et al. (2021)44 | Single-center, open-label, prospective study, 6 months | 20 patients, advanced PD with off time > 1.5 h | 3 | 63.8 (10.2) | 6.0 (2.2) | PD fatigue scale | Significant improvement with safinamide 50 mg; baseline 2.85 ± 0.67 and post 2.20 ± 1.07, P = 0.02 | 0.97 |
Bianchi et al. (2019)45 | Single-center, open-label, retrospective study, 4.4 months | 20 patients, advanced PD with motor fluctuations | 4 | 75.0 (6.3) | 14.5 (6.8) | Physical fatigue scales | No significant change with safinamide 100 mg; baseline 39.4 ± 19.8 and post 39.4 ± 22.5, P = 1.00 | 0.00 |
Mental fatigue scales | No significant change with safinamide 100 mg; baseline 20.0 ± 17.0 and post 20.0 ± 14.1, P = 1.00 | 0.00 |
