XXXX in chronic sensorimotor deficits after @entity385 : A proof of concept study.

@entity1 @entity410 @entity64 @entity390 @entity1295 @entity974 @entity4841 @entity1445 @entity385
OBJECTIVE: To evaluate the safety and tolerability of @entity974 extended release (D-ER) in @entity1 with chronic post- @entity385 , and to assess for potential drug activity on sensorimotor function. METHODS: Using a double-blind, placebo-controlled, cross-over design, @entity1 were randomized to placebo/D-ER or D-ER/placebo sequences and given D-ER 10 mg or placebo twice daily. Key inclusion criteria were: @entity385 >=    6 months, Fugl-Meyer Assessment lower extremity motor score  <=   28, ability to complete Timed 25-Foot Walk (T25FW). The primary outcome was safety and tolerability. The key exploratory measure was walking speed (T25FW). Other assessments were: Box and Block, and Grip and Pinch tests; Functional Independence Measure. Full-crossover data were analyzed using mixed-effects model. RESULTS: A total of 83 @entity1 were randomized: 70 completed and 13 discontinued the study. Adverse events were consistent with previous D-ER trials; no new safety signals were observed. Four @entity1 experienced serious adverse events: 3 @entity410 (1 placebo, 2 D-ER), 1 was secondary to intentional @entity1445 . Most common treatment-emergent adverse events were: dizziness, @entity390 , @entity4841 and @entity1295 . Mixed-effects analysis showed an effect for D-ER vs placebo in improving walking speed (0.21 vs 0.10 ft/s; p   =   0.027). CONCLUSIONS: D-ER was generally well tolerated in @entity1 with @entity64 . Potential drug activity on lower extremity sensorimotor function, with an improvement in walking speed, was seen.
