Table 4.
Comparison of further assessments for tics, comorbidities, and quality of life between iCBIT and placebo at 1 week after end of treatment (V3, primary endpoint) and follow-up visits (V4, V5).
| Assessment (CFB) | Visit | iCBIT: LS Mean (95% CI) | Placebo: LS Mean (95% CI) | LS Mean Diff iCBIT-pl (95% CI) | p-Value |
|---|---|---|---|---|---|
| ATQ | V3 | −7.50 (−11.62; −3.38) | −1.32 (−5.04; 2.40) | −6.18 (−11.57; −0.80) | 0.025 |
| V4 | −10.42 (−14.65; −6.19) | −3.25 (−7.23; 0.73) | −7.17 (−12.78; −1.55) | 0.013 | |
| V5 | −7.80 (−12.35; −3.24) | −1.54 (−5.76; 2.69) | −6.26 (−12.27; −0.25) | 0.041 | |
| CGI-S | V3 | −0.41 (−0.53; −0.29) | −0.15 (−0.26; −0.03) | −0.26 (−0.42; −0.10) | 0.001 * |
| V4 | −0.60 (−0.75; −0.46) | −0.17 (−0.30; −0.04) | −0.43 (−0.62; −0.25) | <0.001 * | |
| V5 | −0.48 (−0.63; −0.32) | −0.27 (−0.41; −0.14) | −0.20 (−0.40; −0.01) | 0.044 * | |
| MRVS | V3 | −0.94 (−1.66; −0.23) | −0.06 (−0.75; 0.63) | −0.88 (−1.84; 0.08) | 0.072 |
| V4 | −1.83 (−2.58; −1.08) | −0.53 (−1.14; 0.28) | −1.40 (−2.40; −0.40) | 0.006 * | |
| V5 | −1.11 (−1.91; −0.30) | −0.24 (−1.01; 0.53) | −0.87 (−1.95; 0.22) | 0.117 | |
| PUTS-9 | V3 | 0.33 (−0.55; 1.20) | −1.13 (−1.92; −0.34) | 1.46 (0.32; 2.59) | 0.012 * |
| V4 | 0.32 (−0.67; 1.31) | −0.45 (−1.35; 0.45) | 0.77 (−0.51; 2.06) | 0.238 | |
| V5 | −0.07 (−1.18; 1.04) | −0.58 (−1.56; 0.40) | 0.51 (−0.92; 1.93) | 0.484 | |
| GTS-QoL | V3 | −3.58 (−5.87; −1.28) | −1.90 (−4.01; 0.20) | −1.67 (−4.67; 1.32) | 0.272 |
| V4 | −6.95 (−9.57; −4.32) | −1.66 (−4.04; 0.72) | −5.28 (−8.69; −1.88) | 0.002 * | |
| V5 | −5.86 (−8.66; −3.05) | −1.26 (−3.76; 1.24) | −4.60 (−8.21; −0.99) | 0.013 * | |
| GTS-QoL-VAS | V3 | −3.49 (−7.05; 0.06) | 3.83 (0.57; 7.09) | −7.32 (−12.02; −2.62) | 0.002 * |
| V4 | 3.80 (−0.08; 7.68) | 2.11 (−1.43; 5.65) | 1.69 (−3.44; 6.82) | 0.517 | |
| V5 | −1.38 (−5.76; 3.01) | 4.31 (0.45; 8.17) | −5.68 (−11.37; 0.00) | 0.050 | |
| Y-BOCS | V3 | −1.57 (−2.48; −0.66) | 0.29 (−0.57; 1.14) | −1.86 (−3.05; −0.67) | 0.002 * |
| V4 | −0.89 (−1.98; 0.20) | −0.66 (−1.66; 0.33) | −0.23 (−1.63; 1.18) | 0.752 | |
| V5 | −1.37 (−2.51; −0.23) | −0.50 (−1.51; 0.52) | −0.87 (−2.33; 0.58) | 0.239 | |
| CAARS: ADHD Index | V3 | −0.98 (−1.83; −0.13) | −0.32 (−1.06; 0.42) | −0.66 (−1.73; 0.41) | 0.227 |
| V4 | −1.85 (−2.81; −0.90) | −0.43 (−1.25; 0.38) | −1.42 (−2.63; −0.21) | 0.021 * | |
| V5 | −0.97 (−2.03; 0.10) | 0.05 (−0.82; 0.93) | −1.02 (−2.34; 0.30) | 0.129 | |
| BDI-II | V3 | −1.98 (−3.51; −0.45) | −0.95 (−2.36; 0.46) | −1.03 (−3.04; 0.98) | 0.312 |
| V4 | −3.36 (−4.97; −1.75) | −1.13 (−2.60; 0.34) | −2.23 (−4.33; −0.12) | 0.038 * | |
| V5 | −1.85 (−3.58; −0.13) | −0.77 (−2.35; 0.81) | −1.09 (−3.34; 1.17) | 0.345 | |
| BAI | V3 | −1.10 (−2.45; 0.24) | 1.06 (−0.18; 2.30) | −2.17 (−3.94; −0.39) | 0.017 * |
| V4 | −1.90 (−3.38; −0.42) | 0.97 (−0.38; 2.32) | −2.87 (−4.81; −0.93) | 0.004 * | |
| V5 | −1.58 (−3.24; 0.09) | −0.16 (−1.66; 1.34) | −1.42 (−3.58; 0.75) | 0.198 |
ATQ: Adult Tic Questionnaire; MRVS: Modified Rush Video-Based Tic Rating Scale; CGI-S: Clinical Global Impression-Severity; PUTS-9: Premonitory Urge for Tics Scale; GTS-QoL: Gilles de la Tourette Syndrome Quality of Life Scale; GTS-QoL-VAS: Quality of Life-Visual Analogue Scale; BDI-II: Beck Depression Inventory-II; BAI: Beck Anxiety Inventory; CAARS: Conners’ Adult ADHD Rating Scales; ADHD: Attention Deficit and Hyperactivity Disorder; Y-BOCS: Yale Brown Obsessive Compulsive Scale; CFB: Change from Baseline; * p < 0.05; bold: trends, p < 0.10.