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. 2020 Jan 14;91(3):254–262. doi: 10.1136/jnnp-2019-322168

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.