Figure 1
Study Design. Timeline of in-person and telephone visits and a list of assessments at each visit. Abbreviations: YGTSS, Yale Global Tic Severity Scale; TS-CGI, Tourette’s Syndrome Clinical Global Impression; PGIC, Patient Global Impression of Change (administered at weeks 2, 4, 8, and 9 only), CY-BOCS, Children’s Yale–Brown Obsessive–Compulsive Scale; BDI-II, Beck Depression Inventory; C-SSRS, Columbia Suicide Severity Rating Scale.
Figure 2
Changes in Total Tic, Motor, and Phonic Tic Scores over Time. Primary efficacy scores were change in mean TTS scores at week 8 following 6 weeks of titration and 2 weeks maintenance dosing with deutetrabenazine. The graph illustrates a reduction in TTS, motor and phonic tic mean scores to week 8 (all p<0.001). When deutetrabenazine was withdrawn, the total and individual scores increased until the last assessment at week 9. Error bars represent the standard deviations. Abbreviations: YGTSS, Yale Global Tic Severity Scale; TTS, YGTSS Total Tic Score; Motor Tic Score, Motor; Vocal Tic Score, Phonic.
Table 1
Mean Change from Baseline to Week 8
| Assessment | Mean (SD) [95% CI for mean]1 | Change from Baseline At Week 8 | |
|---|---|---|---|
| TTS | Baseline | 31.6 (7.9) [28.2, 35.0] | -11.6 (8.2) [-15.3, -7.8] p < 0.00012 |
| Week 8 | 20.8 (11.4) [15.6, 25.9] | ||
| TIS | Baseline | 34.3 (9.4) [30.3, 38.4] | -11.9 (9.3) [-16.1, -7.7] p < 0.0001 |
| Week 8 | 22.9 (11.5) [17.6, 28.1] | ||
| GSS | Baseline | 66.0 (16.0) [59.0, 72.9] | 23.5 (15.7) [-30.6, -16.3] p < 0.0001 |
| Week 8 | 43.6 (22.0) [33.6, 53.7] | ||
| MTSS | Baseline | 17.4 (3.9) [15.7, 19.1] | -6.1 (4.3) [-8.1, -4.1] p < 0.0001 |
| Week 8 | 11.7 (5.4) [9.2, 14.1] | ||
| VTSS | Baseline | 14.2 (5.7) [11.8, 16.7] | -5.5 (4.4) [-7.5, -3.5] p < 0.0001 |
| Week 8 | 9.1 (6.96) [5.9, 12.3] | ||
| TS-CGI | Baseline | 4.7 (0.88) [4.3, 5.1] | -1.2 (0.81) [-1.6, -0.8] p <0.0001 |
| Week 8 | 3.6 (1.16) [3.0, 4.1] | ||
| TS-PGIC | - | - | |
| Week 8 | 1 point rating minimally improved n = 5 (23.8%) 2 point rating much improved n = 12 (57.1%) 3 point rating very much improved n = 4 (57.1%) p < 0.0001 | ||
| BDI-II | Baseline | 14.2 (13.9) (0-52)3 | 21; -5.7 (8.0) (-25, -5) -2.7 (5.5) (-23, 0) p = 0.0352 |
| Week 8 | 8.2 (11.6) (0-33) | ||
| CY-BOCS4 | Baseline | 7.0 (9.2) (0-27) | |
| Week 8 | 4.5 (7.5) (0-25) | ||
{ label (or @symbol) needed for fn[@id='TFN01t01'] } Abbreviations: BDI, Beck Depression Inventory; CGI, Clinical Global Impression; CI, Confidence Interval; CY-BOCS, Children’s Yale–Brown Obsessive Compulsive Scale; GSS, Global Severity Score; max, Maximum; min, Minimum; MTSS, Motor Tic Severity Score; PGIC, Patient Global Impression of Change; SD, Standard Deviation; TIS, Tic-Related Impairment Score; TS, Tourette Syndrome; TTS, Total Tic Severity Score; VTSS, Vocal Tic Severity Score.
Figure 3
TS-CGI Score Reductions at Week 8. Physician ratings of clinical improvement following deutetrabenazine treatment are graphically presented with the number and percentage of patients with score rating reductions by 1, 2, and 3 points occurring between baseline and week 8 TS-CGI assessments. Abbreviations: TS-CGI: Tourette’s Syndrome Clinical Global Impression Scale.
