Table 3 Efficacy measures at baseline and week 8 in ITT population for Adolescent/adult study
From: Arbaclofen in fragile X syndrome: results of phase 3 trials
Measure | Placebo N = 63 (62 completers) | Arbaclofen N = 62 (57 completers) | |||||
|---|---|---|---|---|---|---|---|
Baseline | Week 8 | Change | Baseline | Week 8 | Change | p | |
ABC-CFX SA | 7.9 (3.48) | 5.5 (3.37) | −2.4 (0.32) | 7.6 (3.17) | 5.3 (3.57) | −2.3 (0.33) | 0.974 |
ABC-CFX I | 15.8 (13.18) | 10.8 (11.01) | −5.3 (0.88) | 16.9 (14.58) | 12.3 (12.35) | −4.2 (0.89) | 0.421 |
ABC-CFX H | 11.2 (7.32) | 8.0 (6.75) | −3.4 (0.57) | 12.9 (8.44) | 8.7 (6.82) | −3.6 (0.58) | 0.811 |
ABC-CFX SB | 8.4 (5.77) | 6.0 (5.30) | −2.5 (0.40) | 8.8 (5.37) | 5.7 (4.84) | −2.9 (0.40) | 0.508 |
ABC-CFX L | 12.3 (6.70) | 7.3 (5.38) | −5.2 (0.56) | 12.8 (7.19) | 7.9 (5.94) | −4.7 (0.57) | 0.536 |
ABC-CFX IS | 6.4 (3.74) | 4.6 (3.02) | −1.8 (0.28) | 6.5 (3.90) | 4.8 (3.53) | −1.5 (0.29) | 0.452 |
CGI-I | – | 3.1 (0.12) | – | – | 3.2 (0.12) | – | 0.587 |
CGI-S | 4.7 (0.92) | 4.4 (0.98) | −0.3 (0.08) | 4.6 (1.07) | 4.1 (1.06) | −0.5 (0.08) | 0.063 |
Responder | – | 25.00% | – | – | 24.10% | – | 0.913 |
PSI | 126.5 (20.45) | 129.1 (23.26) | 4.1 (2.23) | 115.4 (22.04) | 120.2 (22.48) | 3.3 (2.27) | 0.816 |
VAS-Anx | 59.9 (24.57) | 39.1 (26.82) | −21.2 (33.31) | 62.0 (27.00) | 46.4 (29.96) | −14.7 (3.38) | 0.176 |
VAS-Dis | 32.9 (28.75) | 27.4 (24.74) | −7.0 (2.67) | 37.6 (33.40) | 33.3 (29.57) | −3.9 (2.72) | 0.413 |
Vineland-II Soc | 55.2 (20.33) | 57.4 (19.70) | 2.5 (1.17) | 53.4 (15.80) | 53.5 (18.17) | 0.1 (1.17) | 0.151 |
Vineland-II Comm | 51.4 (20.91) | 53.4 (20.56) | 1.9 (1.06) | 48.5 (18.54) | 48.9 (19.72) | 0.2 (1.06) | 0.274 |
Vineland-II Mal | 19.6 (1.43) | 19.1 (1.27) | −0.6 (0.16) | 20.0 (1.77) | 19.2 (1.77) | −0.7 (0.16) | 0.638 |
CSHQ-T | 42.4 (6.68) | 41.1 (5.83) | −1.3 (0.44) | 42.7 (7.55) | 41.1 (6.60) | −1.4 (0.45) | 0.857 |
CSHQ-DS | 10.8 (2.26) | 10.7 (2.49) | −0.2 (0.25) | 11.0 (2.83) | 10.7 (2.49) | −0.3 (0.26) | 0.700 |