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Full-Text Articles in Medicine and Health Sciences
Two Phase 3, Multicenter, Randomized, Placebo-Controlled Clinical Trials Of Fampridine-Sr For Treatment Of Spasticity In Chronic Spinal Cord Injury., D. D. Cardenas, J. F. Ditunno, V. Graziani, A. B. Mclain, D. P. Lammertse, P. J. Potter, M. S. Alexander, R. Cohen, A. R. Blight
Two Phase 3, Multicenter, Randomized, Placebo-Controlled Clinical Trials Of Fampridine-Sr For Treatment Of Spasticity In Chronic Spinal Cord Injury., D. D. Cardenas, J. F. Ditunno, V. Graziani, A. B. Mclain, D. P. Lammertse, P. J. Potter, M. S. Alexander, R. Cohen, A. R. Blight
Department of Rehabilitation Medicine Faculty Papers
STUDY DESIGN: Two randomized, double-blind, placebo-controlled trials.
OBJECTIVE: To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).
SETTING: United States and Canada.
METHODS: Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors …