Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials

被引:32
|
作者
Sperling, Michael R. [1 ]
Greenspan, Andrew [2 ]
Cramer, Joyce A. [3 ]
Kwan, Patrick [4 ]
Kalviainen, Reetta [5 ]
Halford, Jonathan J. [6 ]
Schmitt, Jennifer [2 ]
Yuen, Eric [2 ]
Cook, Thomas [7 ]
Haas, Magali [8 ]
Novak, Gerald [2 ]
机构
[1] Thomas Jefferson Univ, Jefferson Comprehens Epilepsy Ctr, Philadelphia, PA 19107 USA
[2] Johnson & Johnson Pharmaceut Res & Dev LLC, Raritan, NJ USA
[3] Yale Univ, Epilepsy Therapy Project, New Haven, CT USA
[4] Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China
[5] Kuopio Univ Hosp, SF-70210 Kuopio, Finland
[6] Med Univ S Carolina, Charleston, SC 29425 USA
[7] Univ Wisconsin, Dept Biostat & Med Informat, Madison, WI USA
[8] Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium
关键词
Adjunctive; Antiepileptic; Carisbamate; Partial-onset seizures; Uridine diphosphate glucuronosyltransferase; CNS DRUG RWJ-333369; ANTIEPILEPTIC DRUGS; EPILEPSY; PHARMACOKINETICS;
D O I
10.1111/j.1528-1167.2009.02318.x
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
P>Purpose: To assess the efficacy, safety, and tolerability of the investigational drug carisbamate as adjunctive treatment for partial-onset seizures (POS). Methods: Two identical, randomized, placebo-controlled, double-blind studies were conducted in adults with POS uncontrolled for >= 1 year. Therapy-refractory epilepsy patients (>= 16 years) remained on stable doses of prescribed antiepileptic drugs (< 2) for an 8-week prospective baseline phase and were then randomized (1:1:1) to carisbamate 200 mg/day, carisbamate 400 mg/day, or placebo, for a 12-week double-blind phase. Primary efficacy end points were percent reduction in seizure frequency and responder rate (patients with >= 50% reduction in POS frequency) during the double-blind phase compared with the prospective baseline phase. Results: Of the 565 patients randomized in study 1, 93% completed the study; of the 562 randomized in study 2, 94% completed the study. Patient characteristics were similar across both studies and treatment arms: mean age, 35 years (study 1, range 16-75 years) and 36 years (study 2, range 16-74 years); approximately 50% were men. Treatment with carisbamate 400 mg/day resulted in significant improvement (p < 0.01) in both efficacy measures compared with placebo in study 1 but not in study 2. Carisbamate 200 mg/day did not differ statistically from placebo in either study. Among the most common treatment-emergent adverse events (>= 5% in any group), those with an incidence exceeding placebo (>= 3%) were dizziness (400 mg/day group) and somnolence. Conclusions: Carisbamate 400 mg/day was effective in patients with refractory partial-onset seizures in one of these global studies. More than 200 mg/day of carisbamate is required for efficacy. Carisbamate was well-tolerated in both studies.
引用
收藏
页码:333 / 343
页数:11
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