title: Dalfampridine in chronic sensorimotor deficits after ischemic stroke: A proof of concept study.
abstract: To evaluate the safety and tolerability of dalfampridine extended release (D-ER) in participants with chronic post-ischemic stroke deficits, and to assess for potential drug activity on sensorimotor function.
  
  
  
  Using a double-blind, placebo-controlled, cross-over design, participants 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: ischemic stroke ≥ 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.
  
  
  
  A total of 83 participants 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 participants experienced serious adverse events: 3 seizures (1 placebo, 2 D-ER), 1 was secondary to intentional overdose. Most common treatment-emergent adverse events were: dizziness, nausea, arthralgia and fatigue. 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).
  
  
  
  D-ER was generally well tolerated in participants with chronic stroke deficits. Potential drug activity on lower extremity sensorimotor function, with an improvement in walking speed, was seen.
authors.affiliation: Mount Sinai Medical Center, Department of Neurology, Box 1052, New York, NY 10029, USA. david.simpson@mssm.edu.
authors.forename: David M
authors.initials: DM
authors.lastname: Simpson
authors.forename: James
authors.initials: J
authors.lastname: Goldenberg
authors.forename: Scott
authors.initials: S
authors.lastname: Kasner
authors.forename: Marshall
authors.initials: M
authors.lastname: Nash
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reding
authors.forename: Richard M
authors.initials: RM
authors.lastname: Zweifler
authors.forename: Gustavo
authors.initials: G
authors.lastname: Suarez
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Herbert R
authors.initials: HR
authors.lastname: Henney
authors.forename: Adrian L
authors.initials: AL
authors.lastname: Rabinowicz
authors.forename: Enrique
authors.initials: E
authors.lastname: Carrazana
mesh_terms: D015761:4-Aminopyridine / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D056228:Feedback, Sensory; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D026902:Potassium Channel Blockers / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D020521:Stroke / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D026902:Potassium Channel Blockers; D015761:4-Aminopyridine