• D D Cardenas, J Ditunno, V Graziani, A B Jackson, D Lammertse, P Potter, M Sipski, R Cohen, and A R Blight.
• Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.
• Spinal Cord. 2007 Feb 1; 45 (2): 158-68.

Study DesignDouble-blind, randomized, placebo-controlled, parallel-group clinical trial.ObjectiveAssess safety and efficacy of sustained-release fampridine in subjects with chronic spinal cord injury.SettingA total of 11 academic rehabilitation research centers in the United States.MethodsA total of 91 subjects with motor-incomplete spinal cord injury (SCI), randomized to three arms: fampridine, sustained release, 25 mg b.i.d. (Group I), 40 mg b.i.d. (Group II), and placebo (Group III) for 8 weeks.Outcome MeasuresPatient diary questionnaire, Ashworth score, American Spinal Cord Injury Association International Standards, International Index of Erectile Function, bladder and bowel management questionnaires, and Clinician and Subject Global Impressions (Clinician Global Impression of change, Subject Global Impression (SGI)). Safety was evaluated from adverse events, physical examinations, vital signs, electrocardiograms, and laboratory tests.ResultsIn total, 78% of the subjects completed the study. More (13/30) discontinued from Group II than Group I (4/30) and Group III (3/31). The most frequent adverse events across groups were hypertonia, generalized spasm, insomnia, dizziness, asthenia, pain, constipation, and headache. One subject in Group II experienced a seizure. SGI changed significantly in favor of Group I (P=0.02). Subgroup analysis of subjects with baseline Ashworth scores >1 showed significant improvement in spasticity in Group I versus III (P=0.02).ConclusionsGroup I showed significant improvement in SGI, and potential benefit on spasticity. The drug was well tolerated. Group II showed more adverse events and discontinuations.

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