Table 2:
Mean baseline values and estimated means (95% CI) for each medication period
| Outcome | Measure | Mean Score | Estimated Mean Score | ||||
|---|---|---|---|---|---|---|---|
| Baseline | Placebo (N=123) |
Amantadine (N=124) |
Modafinil (N=124) |
Methylphenidate (N=127) |
P-value for the overall medication effect$ | ||
| Prespecified primary | MFIS Total | 51.3 (49.0 to 53.6) | 40.6 (38.2 to 43.1) | 41.3 (38.8 to 43.7) | 39.0 (36.6 to 41.4) | 38.6 (36.2 to 41.0) | 0.20 |
| Prespecified secondary | NeuroQoL Fatigue T-score | 58.5 (57.6 to 59.4) | 53.1 (51.9 to 54.3) | 53.0 (51.7 to 54.2) | 52.5 (51.3 to 53.8) | 52.0 (50.8 to 53.2) | 0.42 |
| Prespecified secondary | ESS | 11.1 (10.2 to 11.9) | 9.4 (8.7 to 10.1) | 9.3 (8.6 to 10.1) | 8.3 (7.6 to9.1) | 8.8 (8.1 to 9.6) | 0.071 |
| Post hoc exploratory | MFIS physical subscale | 24.1 (22.9 to 25.3) | 18.9 (17.7 to 20.1) | 19.5 (18.3 to 20.6) | 18.4 (17.2 to 19.6) | 18.0 (16.9 to 19.2) | 0.21 |
| Post hoc exploratory | MFIS cognitive subscale | 22.4 (21.0 to 23.7) | 17.8 (16.6 to 19.0) | 18.0 (16.8 to 19.2) | 17.0 (15.8 to 18.2) | 17.2 (16.0 to 18.4) | 0.42 |
| Post hoc exploratory | MFIS psychosocial subscale | 4.8 (4.5 to 5.2) | 3.9 (3.6 to 4.2) | 3.9 (3.6 to 4.2) | 3.6 (3.3 to 3.9) | 3.4 (3.1 to 3.7) | 0.028 |
ESS: Epworth Sleepiness Scale, MFIS: Modified Fatigue Impact Scale, NeuroQoL: Quality of Life in Neurological Disorders
$
P-value for the overall medication effect in the mixed-effect regression model. The fixed predictors were study medications, treatment sequence, treatment period, the baseline level of the outcome, and the study site. Subjects were the random effect.