A 21-week open-label clinical trial of pregabalin as adjunctive therapy in partial seizures at multiple centers in Mexico (PREPS Mexico)

SummaryPurposeTo investigate the efficacy of pregabalin in the treatment of refractory partial seizures.MethodsThis was a 21-week, open-label study of pregabalin (150–600 mg/day) as an adjunctive therapy in adults with refractory partial seizures. The study included an 8-week baseline period, a 9-week dose-optimization period, and a 12-week treatment-observation period. The primary assessment was mean percentage change in 28-day seizure rate between baseline and the last 12 weeks of treatment.ResultsIn total, 136 Mexican patients were included in this study (55.9% women; mean age/epilepsy duration, 35.2/22.9 years). The median and mean (95% confidence interval [CI]) 28-day baseline seizure rates were 3.9 and 7.8 (5.4–10.2), respectively. The mean (95% CI) reduction in seizure frequency was 51.2% (43.0–59.3) over the last 12 weeks of treatment, while the median reduction was 57.9%. The percentage of patients with a ≥50% or ≥75% reduction in seizure frequency was 63.6% and 48.8%, respectively. The percentage of patients who were seizure-free during the last 4 and 12 weeks of treatment was 40.5% and 20.7%, respectively. The most common adverse events were somnolence (39.7%), dizziness (16.2%), and weight gain (14.0%).ConclusionPregabalin was well tolerated and associated with significant reductions in seizure frequency.