Table 2.
Primary and Secondary Efficacy Measures (ITT Population)
| Dasotraline 4 mg (N = 161) | Dasotraline 6 mg (N = 162) | Placebo (N = 162) | Treatment Difference (vs. Placebo) | |||
|---|---|---|---|---|---|---|
| Primary efficacy variable | LS mean (SE) | LS mean (SE) | LS mean (SE) | LS mean (SE) difference (4 mg/6 mg) | Effect size (4 mg/6 mg) | P value a(4 mg/6 mg) |
| Binge-eating days/week | −3.2 (0.1) | −3.5 (0.1) | −2.9 (0.1) | −0.3 (0.2)/−0.6 (0.2) | 0.19/0.35 | .119/.0045 |
| Secondary efficacy variables | LS mean (SE) | LS mean (SE) | LS mean (SE) | LS mean (SE) difference (4 mg/6 mg) | Effect size (4 mg/6 mg) | P value (4 mg/6 mg) |
| BE-CGI-Severity | −2.1 (0.1) | −2.3 (0.1) | −1.8 (0.1) | −0.4 (0.2)/−0.5 (0.2) | 0.27/0.37 | .0256/.0025 |
| YBOCS-BE total score | −14.1 (0.7) | −15.2 (0.7) | −11.8 (0.7) | −2.3 (1.0)/−3.4 (1.0) | 0.29/0.43 | .0154/.0005 |
| Obsession subscale score | −6.7 (0.3) | −7.4 (0.4) | −5.6 (0.3) | −1.2 (0.5)/−1.9 (0.5) | 0.29/0.46 | .0151/.0002 |
| Compulsion subscale score | −7.3 (0.4) | −7.8 (0.4) | −6.2 (0.4) | −1.1 (0.5)/−1.5 (0.5) | 0.26/0.37 | .0273/.0027 |
| EDE-QM global score (restraint, eating concern,shape concern, and weight concern) b | −1.20 (0.12) | −1.35 (0.12) | −0.54 (0.12) | −0.66 (0.16)/−0.81 (0.16) | 0.49/0.59 | <.0001/<.0001 |
| SDS total score | −8.6 (0.55) | −8.2 (0.58) | −6.1 (0.55) | −2.4 (0.8)/−2.1 (0.8) | 0.41/0.34 | .0018/.0103 |
| Work/school subscale score | −1.9 (0.19) | −1.8 (0.20) | −1.3 (0.19) | −0.6 (0.3)/−0.5 (0.3) | 0.30/0.25 | .0225/.0643 |
| Social life subscale score | −3.5 (0.20) | −3.4 (0.21) | −2.4 (0.19) | −1.1 (0.3)/−1.0 (0.3) | 0.50/0.44 | <.0001/.0005 |
| Family life/home subscale score | −2.9 (0.18) | −3.0 (0.19) | −2.4 (0.18) | −0.6 (0.25)/−0.6 (0.26) | 0.27/0.30 | .0256/.0185 |
| Binge-eating episodes/week | −4.3 (0.2) | −4.4 (0.2) | −3.7 (0.2) | −0.6 (0.3)/−0.7 (0.3) | 0.23/0.25 | .0495/.0372 |
| N (%) | N (%) | N (%) | NNT (4 mg/6 mg) | Odds ratio | P value | |
| 4-week BE-cessation at EOT (ITT) c | 54/161 (33.5) | 55/162 (34.0) | 49/162 (30.2) | 31/27 | 1.2/1.2 | ns/ns |
| 4-week BE-cessation at EOT d (completer) | 47/123 (38.2) | 51/106 (48.1) | 45/131 (34.4) | 26/8 | 1.2/1.8 | ns/.0298 |
Abbreviations: BE-CGI-S, Binge-Eating Clinical Global Impression–Severity; CI, confidence interval; EDE-QM: Eating Disorder Examination Questionnaire, modified; EOT, end of treatment; ITT, intention-to-treat; LS, least squares; ns, not significant (P > .05); SDS, Sheehan Disability Scale; SE, standard error; YBOCS-BE, Yale-Brown Obsessive–Compulsive Scale Modified for binge-eating.
P values for the primary efficacy variable is based on hierarchical testing controlled for overall type I error; P values for secondary efficacy variables are nominal (exploratory) P values.
Evaluated using Analysis of Covariance (ANCOVA at LOCF-endpoint).
Proportion of patients having no binge-eating episodes in the final four study weeks was evaluated using a logistic regression model for LOCF-endpoint sample.
This completer analysis was post-hoc.