• 1. Department of Neurology, West China Hospital of Sichuan University, Chengdu 610041, China;
  • 2. Department of Neurology, Sichuan Provincial People's Hospital, Chengdu 614800, China;
  • 3. Epilepsy center, Lanzhou University Second Hospital, Lanzhou 730000, China;
  • 4. Department of Neurology, Jilin University, Changchun 130021, China;
  • 5. Department of Neurology, Qilu Hospital of Shandong University, Ji'nan 250002, China;
  • 6. Department of Neurology, Ji'nan Central Hospital, Ji'nan 250002, China;
  • 7. Department of medical psychology, General Hospital of PLA, Beijing 100853, China;
  • 8. Department of Neurology, The First Affiliated Hospital of Bengbu Medical College Bengbu, Bengbu 233005, China;
  • 9. Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan 430033, China;
  • 10. Department of Neurology, Renmin Hospital of Wuhan University, Wuhan 430200, China;
  • 11. Department of Neurology, People's Hospital of Jiangxi Province, Nanchang 330006, China;
  • 12. Department of Neurology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou 510120, China;
  • 13. Institute of Neuroscience, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510000, China;
  • 14. Department of Neurology, First Affiliated Hospital of Shanxi Medical University, Taiyuan 030001, China;
  • 15. Department of Neurology, Liaocheng People's Hospital, Liaocheng 252002, China;
ZHOUDong, Email: zhoudong66@yahoo.de
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Objectives To evaluate the efficacy and safety of lacosamide (200mg/d and 400mg/d)when added to 1 to 3 antiepileptic drugs (AEDs) in adults with uncontrolled partial-onset seizures. Methods During this multicenter, double-blind, placebo-controlled trial, patients were randomized to placebo or lacosamide 200 or 400mg/day after an 8-week baseline period. Lacosamide was titrated in weekly increments to target dose over 4 weeks and maintained for 12 weeks followed by 12 weeks for withdrawal. The reductions of seizure frequence during maintain period and proportion of ≥50% reduction of seizures frequence were analysed. Besides,adverse effects were also recorded. Results Five hundred fourty patients were randomized, 515 patients completed the trial (Full analysis set, FAS), including 394 were per-protocol set (PPS). The reduction of seizure frequence during maintain period every 4 weeks among 200mg/d,400mg/d group and placebo group were 26.35%,40.12%,21.69%(P=0.000 5) and 25.61%,46.86%,23.06%(P<0.000 1), respectively in FAS and PPS. The proportion of ≥50% reduction of seizures frequence among three groups were 29.82%,38.15%,22.49%(P=0.006 8) and 27.94%,42.37%,22.86%(P=0.002 3), respectively in FAS and PPS. The incidences of adverse events were 5.84%, 36.11%, 19.55% among three groups. Compared with each other, there was statistic significance between 400mg/d and placebo groups. Conclusion In this trial, adjunctive lacosamide significantly reduced seizure frequency in patients with uncontrolled partial-onset seizures. Along with favorable pharmacokinetic and tolerability profiles, these results support further development of lacosamide as an AED.

Citation: WUXintong, SUNHongbin, WANGWeimin, LINWeihong, YANChuanzhu, LIXiaohong, LANGSenyang, QUHongdang, ZHUSuiqiang, LUZuneng, ZHANGKunnan, TAOEnxiang, LIAOWeiping, SUNMeizhen, GUOCunju, YANBo, HAONanya, ZHOUDong. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized placebo-controlled trial. Journal of Epilepsy, 2015, 1(1): 5-16. doi: 10.7507/2096-0247.20150001 Copy

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