Table 1.
Baseline demographics and characteristics of the full analysis set
| KPS1301 study | KPS1305 study | Pooled group* | |||||
| Placebo (n=123) |
Rovatirelin 1.6 mg (n=124) | Rovatirelin 2.4 mg (n=122) | Placebo (n=101) |
Rovatirelin 2.4 mg (n=101) | Placebo (n=138) |
Rovatirelin 2.4 mg (n=140) | |
| Age, years | 62.1±10.6 | 64.3±11.2 | 62.7±10.8 | 66.5±9.0 | 63.5±12.1 | 65.5±9.9 | 64.0±11.5 |
| Sex, n (%) | |||||||
| Male | 67 (54.5) | 64 (51.6) | 64 (52.5) | 49 (48.5) | 57 (56.4) | 73 (52.9) | 76 (54.3) |
| Female | 56 (45.5) | 60 (48.4) | 58 (47.5) | 52 (51.5) | 44 (43.6) | 65 (47.1) | 64 (45.7) |
| Disease duration, years | 9.8±7.3 | 9.9±6.4 | 10.3±7.4 | 9.6±6.6 | 9.9±6.9 | 10.0±6.4 | 11.0±7.8 |
| Type of SCA, n (%) | |||||||
| SCA6 | 42 (34.1) | 64 (51.6) | 59 (48.4) | 44 (43.6) | 39 (38.6) | 64 (46.4) | 56 (40.0) |
| SCA31 | 28 (22.8) | 25 (20.2) | 19 (15.6) | 29 (28.7) | 28 (27.7) | 35 (25.4) | 32 (22.9) |
| CCA | 53 (43.1) | 35 (28.2) | 44 (36.1) | 28 (27.7) | 34 (33.7) | 39 (28.3) | 52 (37.1) |
| Participation in previous rovatirelin study, n (%) | 0 | 0 | 0 | 7 (6.9) | 7 (6.9) | 0 | 0 |
| SARA total score, points | 12.78±4.10 | 13.31±4.24 | 12.72±4.83 | 14.70±3.37 | 15.03±3.71 | 15.36±3.43 | 15.65±4.07 |
| <15, n (%) | 83 (67.5) | 88 (71.0) | 84 (68.9) | 59 (58.4) | 55 (54.5) | 67 (48.6) | 66 (47.1) |
| ≥15, n (%) | 40 (32.5) | 36 (29.0) | 38 (31.1) | 42 (41.6) | 46 (45.5) | 71 (51.4) | 74 (52.9) |
Data are presented as mean±SD unless stated otherwise.
*KPS1301 subgroup (excluding 1.6 mg) and KPS1305 (excluding subject who participated in previous rovatirelin clinical study).
CCA, cortical cerebellar atrophy; SARA, Scale for Assessment and Rating of Ataxia; SCA, spinocerebellar ataxia.