Results: The final ISCIPDS:B contains core questions about clinically relevant information concerning SCIrelated pain that can be collected by health-care professionals with expertise in SCI in various clinical settings. The questions concern pain severity, physical and emotional function and include a pain-intensity rating, a pain classification and questions related to the temporal pattern of pain for each specific pain problem. The impact of pain on physical, social and emotional function, and sleep is evaluated for each pain.

Patients with SCI must deal with a number of secondary complications in addition to any disability caused by the injury itself. Of 7 symptoms studied, pain, weakness, and fatigue appeared to be most common and most closely linked to patient social and mental health functioning. Research is needed to identify the causal relationships between perceived symptoms and quality of life in patients with SCI and to identify effective treatments for those symptoms shown to impact patient functioning.

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 and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women). Results: The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were À0.15 (placebo) and À0.19 (fampridine-SR) in the first study, and À0.16 (placebo) and À0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments. Conclusion: Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.

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