Randomized, multicenter, dose-ranging trial of retigabine for partial-onset seizures
| Autor: | Porter R. J., Partiot A., Sachdeo R., Nohria V., Alves W. M., on behalf of the 205 Study Group, BARUZZI, AGOSTINO |
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| Přispěvatelé: | Porter R.J., Partiot A., Sachdeo R., Nohria V., Alves W.M., Baruzzi A., on behalf of the 205 Study Group. |
| Jazyk: | angličtina |
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Adolescent Population Phenylenediamines Placebo Risk Assessment chemistry.chemical_compound Epilepsy Risk Factors medicine Humans Adverse effect education Aged education.field_of_study Dose-Response Relationship Drug Seizure types business.industry Retigabine Australia Middle Aged Clinical Science medicine.disease United States Europe Treatment Outcome chemistry Tolerability Anesthesia Anticonvulsants Female Neurology (clinical) Carbamates Epilepsies Partial medicine.symptom business Somnolence |
| Popis: | To evaluate the efficacy and safety of retigabine 600, 900, and 1,200 mg/day administered three times daily as adjunctive therapy in patients with partial-onset seizures.A multicenter, randomized, double-blind, placebo-controlled trial was performed. After an 8-week baseline phase, patients were randomized to a 16-week double-blind treatment period (8-week forced titration and 8-week maintenance) followed by either tapering or entry into an open-label extension study. Primary efficacy was the percentage change from baseline in monthly seizure frequency and compared across treatment arms. Secondary efficacy comparisons included the proportion of patients experiencing/=50% reduction in seizure frequency (responder rate), emergence of new seizure types, and physician assessment of global clinical improvement. Safety/tolerability assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory evaluations. Efficacy analyses were performed on the intent-to-treat population.Of the 399 randomized patients, 279 (69.9%) completed the double-blind treatment period. The median percent change in monthly total partial seizure frequency from baseline was -23% for 600 mg/day, -29% for 900 mg/day, and -35% for 1,200 mg/day vs -13% for placebo (p0.001 for overall difference across all treatment arms). Responder rates for retigabine were 23% for 600 mg/day, 32% for 900 mg/day (p = 0.021), and 33% for 1,200 mg/day (p = 0.016), vs 16% for placebo. The most common treatment-emergent AEs were somnolence, dizziness, confusion, speech disorder, vertigo, tremor, amnesia, abnormal thinking, abnormal gait, paresthesia, and diplopia.Adjunctive therapy with retigabine is well tolerated and reduces the frequency of partial-onset seizures in a dose-dependent manner. |
| Databáze: | OpenAIRE |
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