Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in Chinese patients with refractory partial-onset seizures

Epilepsia

Volumn 50, Issue 3, 2009, Pages 398-405

  Wu, Xun Yi ^a   Hong, Zhen ^a   Wu, Xun ^b   Wu, Li Wen ^c   Wang, Xue Feng ^d   Zhou, Dong ^e   Zhao, Zhong Xin ^f   Lv, Chuan Zhen ^a  

^a FUDAN UNIVERSITY   (China)

^b PEKING UNIVERSITY FIRST HOSPITAL   (China)

^c PEKING UNION MEDICAL COLLEGE   (China)

^d CHONGQING MEDICAL UNIVERSITY   (China)

^e SICHUAN UNIVERSITY   (China)

^f SECOND MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

Add on therapy; Chinese patients; Epilepsy; Levetiracetam; Partial onset seizures; Refractory seizu res

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; CLONAZEPAM; ETIRACETAM; GABAPENTIN; LAMOTRIGINE; PHENOBARBITAL; PHENYTOIN; PLACEBO; TOPIRAMATE; VALPROIC ACID;

ADD ON THERAPY; ADOLESCENT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTICONVULSANT THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPILEPSY; FEMALE; FOCAL EPILEPSY; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ONSET AGE; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SIDE EFFECT; SOMNOLENCE; THROMBOCYTE COUNT; TREATMENT RESPONSE;

ADOLESCENT; ADULT; ANTICONVULSANTS; CHINA; CROSS-CULTURAL COMPARISON; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PIRACETAM; YOUNG ADULT;

EID: 61849102266     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2008.01729.x     Document Type: Article

References (20)

1. Ben-Menachem E, Falter U 2000) Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: a multicenter, double-blind, responder-selected study evaluating monotherapy. European Levetiracetam Study Group. Epilepsia 41 : 1276 1283.
2. Berkovic S, Knowlton R, Leroy R, Schiemann J, Falter U, N01057 Study Group 2007) Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy. Neurology 69 : 1751 1760.
3. Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ 2007) Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology 68 : 402 408.
4. Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I 2000) Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology 55 : 236 242.
5. De Smedt T, Raedt R, Vonck K, Boon P 2007) Levetiracetam: the profile of a novel anticonvulsant drug - Part 1: preclinical data. CNS Drug Rev 13 : 43 56.
6. European Commission 1991) Guidelines for good clinical practice. Directive 91/507/EEC, 19 July.
7. Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z, N159 Study Group 2006) Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neuro-logy 66 : 1654 1660.
8. Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F 2007) Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure 16 : 402 409.
9. International League Against Epilepsy 1981) Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia 22 : 489 501.
10. Kaminski RM, Matagne A, Leclercq K, Gillard M, Michel P, Kenda B, Talaga P, Klitgaard H 2008) SV2A protein is a broad-spectrum anticonvulsant target: Functional correlation between protein binding and seizure protection in models of both partial and generalized epilepsy. Neuropharmacol 54 : 715 720.
11. Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh SM, Matagne A, Fuks B 2004) The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci U S A 101 : 9861 9866.
12. Margineanu DG, Klitgaard H 2000) Inhibition of neuronal hypersynchrony in vitro differentiates levetiracetam from classical antiepileptic drugs. Pharmacol Res 42 : 281 285.
13. Meencke HJ, Buyle S 2006) Assessment of a dose-response relationship of levetiracetam. Eur J Neurol 13 : 942 946.
14. Noachtar S, Andermann E, Meyvisch P, Andermann F, Gough WB, Schiemann-Delgado J, N166 Levetiracetam Study Group 2008) Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures. Neurology 70 : 607 616.
15. Patsalos PN 2004) Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet 43 : 707 724.
16. Perucca E, Gidal BE, Baltes E 2003) Effects of antiepileptic comedication on levetiracetam pharmacokinetics: a pooled analysis of data from randomized adjunctive therapy trials. Epilepsy Res 53 : 47 56.
17. Pigeolet E, Jacqmin P, Sargentini-Maier ML, Stockis A 2007) Population pharmacokinetics of levetiracetam in Japanese and Western adults. Clin Pharmacokinet 46 : 503 512.
18. Shorvon SD, Lowenthal A, Janz D, Bielen E, Loiseau P 2000) Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia 41 : 1179 1186.
19. 14C-levetiracetam, a new antiepileptic agent, in healthy volunteers. Eur J Clin Pharmacol 59 : 621 630.
20. Zhao Q, Jiang J, Li X, Lu ZS, Hu P 2007) Single-dose pharmacokinetics of levetiracetam in healthy Chinese male subjects. Br J Clin Pharmacol 63 : 614 617.