Table 2

Secondary endpoints

KPS1301 studyKPS1305 study
Placebo
(n=123)
Rovatirelin 1.6 mg (n=124)Rovatirelin 2.4 mg (n=122)Placebo
(n=101)
Rovatirelin 2.4 mg (n=101)
SARA total score, points
Change from baseline at week 4−0.52±1.60−0.38±1.71−0.89±1.41−0.50±1.36−0.82±1.45
 P value (vs placebo)0.4900.0580.105
Change from baseline at week 12−0.91±1.89−0.88±1.86−1.05±1.79−0.94±1.97−1.43±1.85
 P value (vs placebo)0.9300.5650.080
Change from baseline at week 24−1.25±2.53−0.90±2.04−1.23±2.10−1.13±2.09−1.46±2.19
 P value (vs placebo)0.2470.9460.303
Change from baseline at final evaluation−1.15±2.57−0.75±2.05−1.22±2.13−1.05±2.20−1.45±2.12
 P value (vs placebo)0.1760.8140.194
SF-8 score, points
 PCS at baseline41.820±7.30742.900±7.16942.904±7.62343.378±6.48644.250±6.410
 PCS at week 1242.271±7.30441.300±7.54642.273±6.83042.473±7.11543.856±6.776
 PCS at week 2442.771±7.18441.446±7.39141.808±7.74941.696±7.14743.856±7.679
 PCS at final evaluation42.498±7.36841.005±7.62741.052±7.77641.662±7.21843.827±7.589
 MCS at baseline48.279±7.13647.499±7.92548.292±7.47647.959±6.73948.063±6.546
 MCS at week 1247.005±6.13645.636±6.90145.389±6.80446.384±5.93745.198±7.198
 MCS at week 2445.230±6.68844.801±6.96645.172±6.48245.766±6.47244.802±7.588
 MCS at final evaluation45.130±6.61744.340±7.20044.990±6.41845.744±6.45644.744±7.807
  • Data are presented as mean±SD. Two-sample t-test was used.

  • MCS, Mental Component Score; PCS, Physical Component Score; SARA, Scale for Assessment and Rating of Ataxia; SF-8, Short Form-8 Health Survey.