Table 2.
Endpoint | Difference from Placebo (95% CI); P Value |
|||
---|---|---|---|---|
Solriamfetol, 300 mg | Solriamfetol, 150 mg | Solriamfetol, 75 mg | Solriamfetol, 37.5 mg | |
MWT, LS mean difference | 12.8 (10.0 to 15.6); <0.0001 | 10.7 (8.1 to 13.4); <0.0001 | 8.9 (5.6 to 12.1); <0.0001 | 4.5 (1.2 to 7.9); 0.0086 |
ESS, LS mean difference | −4.7 (−5.9 to −3.4); <0.0001 | −4.5 (−5.7 to −3.2); <0.0001 | −1.7 (−3.2 to −0.2); 0.0233 | −1.9 (−3.4 to −0.3); 0.0161 |
PGI-C, % difference | 39.6 (28.7 to 50.4); <0.0001 | 40.5 (29.8 to 51.3); <0.0001 | 23.3 (8.6 to 38.0); 0.0035 | 6.2 (−9.7 to 22.2); 0.4447 |
Definition of abbreviations: CI = confidence interval; ESS = Epworth Sleepiness Scale; LS = least squares; MWT = Maintenance of Wakefulness Test; PGI-C = Patient Global Impression of Change.
A fixed hierarchical testing procedure was used to correct for multiplicity, starting with the highest solriamfetol dose for the coprimary endpoints and followed by the key secondary endpoint; testing proceeded in that order for each subsequent lower dose, with statistical significance claimed only for those outcomes above the break in the hierarchy.