Table 2

Responders to primary and secondary endpoints

Response definitionARAT subtest 2 (grasp) primary outcomeARAT total responsemodified Rankin ScaleBarthel IndexFMAOne or more of ARAT, mRS or BI, (%)
≥2 point improvement, (%) >6 point improvement, (%) >1 category improvement, (%)>9 point improvement*, (%)>10 point improvement†, (%)
3 months1/23 (4)3/23 (13)7/23 (30)8/23 (35)4/10 (40)13/23 (57)
6 months3/22 (14)4/22 (18)6/22 (27)7/22 (32)13/22 (59)
12 months3/20 (15)5/20 (25)7/20 (35)8/20 (40)3/10 (30)14/20 (70)
  • *Improvement by the specified threshold could not be evaluated in three subjects in whom baseline score was 100 and three subjects in whom baseline score was 95.

  • †Response on Fugl-Meyer Assessment is ≥10 points on either Motor Function Upper Extremity score or Motor Function Lower Extremity score.

  • ARAT, signifies Action Research Arm Test; BI, Barthel Index; FMA, Fugl-Meyer Assessment; mRS, modified Rankin Scale.