Pregabalin—dosed flexibly 150-600 mg/d (BID)—was evaluated in a 13-week, double-blind, randomized, placebo-controlled trial as treatment of central neuropathic pain associated with SCI. This open-label, 9-month extension study enrolled compliant patients with no serious treatment-associated adverse events (AEs). Open-label treatment was initiated with pregabalin 150 mg/d BID within 1 week of concluding double-blind. Dosage adjustments from 150-600 mg/d were allowed to optimize efficacy and tolerability. Quarterly drug holidays lasted 3-28 days; if patients relapsed (ie, pain worsened at least "moderately"), they returned to treatment. Patients who did not relapse during a drug holiday were withdrawn. Efficacy was assessed by the SF-MPQ and safety by AEs and clinical and laboratory assessments. Of 104 patients entering open-label, 1 was not treated, 60 completed the study's 9 months, 43 discontinued. 51 had received double-blind pregabalin, 53 placebo. Mean weighted dosage of pregabalin was 388 mg/d (estimated average excluding drug holidays). At endpoint, patients showed improvements from baseline in mean sensory (-0.7, SD=5.8), affective (-0.3, SD=2.8), and total (-1.0, SD=8.1) SF-MPQ scores. Improvements were also evident on the pain VAS (-7.9, SD=25.2) and PPI (-0.3, SD=1.2) scales. Most patients (n=88) rated their pain during drug holidays as "very much" or "much" worse (70.5%); 3 patients were withdrawn because they did not relapse during a drug holiday. The most frequent treatment-associated AEs were somnolence (18.4%), dizziness (16.5%), asthenia (12.6%), nausea (11.7%), and constipation and insomnia (10.7% each). 3.9% of patients had serious treatment-associated AEs; 14.6% withdrew because of AEs. One patient died of nontreatment-related cancer. Changes in other safety measures were not clinically meaningful. Results of this long-term study of pregabalin as treatment for chronic central neuropathic pain after SCI demonstrated sustained analgesic effect for ≥1 year. The AE profile observed with long-term treatment was consistent with that described in reports of short-term trials.