Table 2

Efficacy results (based on the intention-to-treat population)

VariableTopiramate (N = 14)Placebo (N = 13)p ValueCI
Mean TTS (baseline)26.64 (8.78)28.77 (7.53)
Mean TTS (visit 5)12.36 (12.04)23.10 (8.99)−18.43 to −1.31
Mean change from baseline TTS (visit 5)*−14.29 (10.47)−5.00 (9.88)0.0259
Mean TMTS (baseline)13.93 (4.70)14.23 (4.21)
Mean TMTS (visit 5)8.14 (5.95)12.80 (6.63)−9.02 to −0.02
Mean change from baseline TMTS (visit 5)−5.79 (5.67)−1.30 (4.35)0.0493
Mean TPTS (baseline)12.71 (5.36)14.54 (5.38)
Mean TPTS (visit 5)4.21 (6.72)10.30 (5.93)−11.17 to −0.18
Mean change from baseline TPTS (visit 5)−8.50 (6.10)−3.70 (8.41)0.0435
Mean GSS (baseline)57.36 (20.04)58.00 (18.86)
Mean GSS (visit 5)20.21 (24.96)50.10 (18.08)−47.94 to −11.21
Mean change from baseline GSS (visit 5)−37.14 (24.73)−8.00 (22.48)0.0030
  • *A component of the Yale Global Tic Severity Scale, the change from baseline in Total Tic Score (TTS) at visit 5 (day 70) is the predefined primary endpoint

  • GSS, Global Severity Score; TMTS, Total Motor Tic Score; TPTS, Total Phonic Tic Score.