Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: A double-blind, randomized, placebo-controlled trial

Epilepsia

Volumn 50, Issue 3, 2009, Pages 406-414

  Peltola, Jukka ^a   Coetzee, Christo ^c   Jiménez, Fiacro ^d   Litovchenko, Tetyana ^e   Ramaratnam, Sridharan ^f   Zaslavaskiy, Leonid ^g   Lu, Zhihong ^h   Sykes, Deanne M ^b,h  

^a TAMPERE UNIVERSITY HOSPITAL   (Finland)

^b Levetiracetam XR N01235 Study Group

^c Umhlanga Hospital   (South Africa)

^d Umhlanga Hospital ^*  (Mexico)

^e KHARKIV MEDICAL ACADEMY OF POSTGRADUATE EDUCATION   (Ukraine)

^f APOLLO HOSPITALS   (India)

^g Leningrad Regional Clinical Hospital   (Russian Federation)

^h UCB PHARMA   (Belgium)

Author keywords

Epilepsy; Extended release; Levetiracetam; Partial onset seizures; Randomized controlled trials; Seizure freedom

Indexed keywords

ANTICONVULSIVE AGENT; ETIRACETAM; PLACEBO;

ADJUVANT THERAPY; ADOLESCENT; ADULT; AGED; ANTICONVULSANT THERAPY; ARTICLE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOCAL EPILEPSY; HEADACHE; HUMAN; INFLUENZA; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; NAUSEA; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; RECOMMENDED DRUG DOSE; RHINOPHARYNGITIS; SCHOOL CHILD; SEIZURE; SIDE EFFECT; SOMNOLENCE; SUSTAINED RELEASE PREPARATION; TABLET FORMULATION; TREATMENT OUTCOME;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; ANTICONVULSANTS; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PIRACETAM; PROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 61849127705     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2008.01817.x     Document Type: Article

References (22)

1. Abou-Khalil B 2005) Benefit-risk assessment of levetiracetam in the treatment of partial seizures. Drug Saf 28 : 871 890.
2. 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.
3. Beydoun A, Kutluay E 2003) Adjunctive clinical trials in epilepsy: is a placebo arm necessary? Epilepsy Behav 4 : 4 5.
4. Bialer M 2007) Extended-release formulations for the treatment of epilepsy. CNS Drugs 21 : 765 774.
5. Boon P, Chauvel P, Pohlmann-Eden B, Otoul C, Wroe S 2002) Dose-response effect of levetiracetam 1000 and 2000 mg/day in partial epilepsy. Epilepsy Res 48 : 77 89.
6. Bourgeois BF 2000) Pharmacokinetic properties of current antiepileptic drugs: what improvements are needed? Neurology 55 : S11 S16.
7. 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.
8. Chaisewikul R, Privitera MD, Hutton JL, Marson AG (2001) Levetiracetam add-on for drug-resistant localization related (partial) epilepsy. Cochrane Database Syst Rev Issue 1. Art. N.: CD001901.
9. Claxton AJ, Cramer J, Pierce C 2001) A systematic review of the associations between dose regimens and medication compliance. Clin Ther 23 : 1296 1310.
10. Commission on Classification and Terminology of the International League against Epilepsy. (1989) Proposal for revised classification of epilepsies and epileptic syndromes. Epilepsia 30 : 389 399.
11. Cramer J, Vachon L, Desforges C, Sussman NM 1995) Dose frequency and dose interval compliance with multiple antiepileptic medications during a controlled clinical trial. Epilepsia 36 : 1111 1117.
12. Cramer JA, Glassman M, Rienzi V 2002) The relationship between poor medication compliance and seizures. Epilepsy Behav 3 : 338 342.
13. Glauser TA, Ayala R, Elterman RD, Mitchell WG, Van Orman CB, Gauer LJ, Lu Z 2006) Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology 66 : 1654 1660.
14. Greenberg RN 1984) Overview of patient compliance with medication dosing: a literature review. Clin Ther 6 : 592 599.
15. Leppik I, Morrell M, Godfroid P, Arrigo C 2003) Seizure-free days observed in randomized placebo-controlled add-on trials with levetiracetam in partial epilepsy. Epilepsia 44 : 1350 1352.
16. Meencke HJ, Buyle S 2006) Assessment of a dose-response relationship of levetiracetam. Eur J Neurol 13 : 942 946.
17. Niklson I, Edrich P, Verdru P 2006) Identifying baseline characteristics of placebo responders versus nonresponders in randomized double-blind trials of refractory partial-onset seizures. Epileptic Disord 8 : 37 44.
18. Olshansky B 2007) Placebo and nocebo in cardiovascular health: implications for healthcare, research, and the doctor-patient relationship. J Am Coll Cardiol 49 : 415 421.
19. Radtke RA 2001) Pharmacokinetics of levetiracetam. Epilepsia 42 (Suppl. 4 24 27.
20. Rouits E, Burton I, Guénolé E, Troenaru M, Bendahmane S, Sargentini-Maier ML 2007) Single- and multiple-dose bioequivalence and food effect comparison between levetiracetam extended release tablets once daily and levetiracetam immediate release tablets twice daily in healthy subjects. American Epilepsy Society 61st Annual Meeting Philadelphia, PA: Program No. 3.233. Accessed December 21, 2007 from http://www.aesnet.org/go/publications/ aes-abstracts/abstract-search/?Mode=display&st=Rouits&sy=2007&sb= All&startrow=1&id=7979.
21. 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.
22. Sommerville KW 2006) Bioequivalence in development of antiepileptic drugs. Epilepsy Res 68 : 82 85.