Dose-response population analysis of levetiracetam add-on treatment in refractory epileptic patients with partial onset seizures

Epilepsy Research

Volumn 73, Issue 3, 2007, Pages 284-291

  Snoeck, Eric ^a   Stockis, Armel ^b  

^a Exprimo NV   (Belgium)

^b Global Pharmacometrics   (Belgium)

Author keywords

Dose response; Epilepsy; Levetiracetam; Modeling and simulation; NONMEM; Poisson

Indexed keywords

ETIRACETAM; PLACEBO;

ADD ON THERAPY; ARTICLE; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE INTERVAL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; EPILEPSY; FOCAL EPILEPSY; GENDER; HUMAN; MAJOR CLINICAL STUDY; PATIENT CODING; PHASE 3 CLINICAL TRIAL; POISSON DISTRIBUTION; PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; WORLD HEALTH ORGANIZATION;

ANTICONVULSANTS; CLINICAL TRIALS, PHASE III; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; NONLINEAR DYNAMICS; PIRACETAM; SEIZURES;

EID: 33847287327     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2006.11.006     Document Type: Article

References (19)

1. In: Beal S.L., and Sheiner L.B. (Eds). NONMEM User's Guide. NONMEM Project Group (1992), University of California at San Francisco, San Francisco
2. Ben-Menachem E., Falter U., and for the European Levetiracetam Study Group. Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: a multicenter, double-blind, responder-selected study evaluating monotherapy. Epilepsia 41 (2000) 1276-1283
3. Betts T., Waegemans T., and Crawford P. A multicentre, double-blind, randomized, parallel group study to evaluate the tolerability and efficacy of two oral doses of levetiracetam, 2000 mg daily and 4000 mg daily, without titration in patients with refractory epilepsy. Seizure 9 (2000) 80-87
4. Breslow N.E., and Clayton D.G. Approximate inference in generalized linear mixed models. J. Am. Stat. Assoc. 88 (1993) 9-25
5. Cereghino J.J., Biton V., Abou-Khalil B., Dreifuss F., Gauer L.J., and Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology 55 (2000) 236-242
6. Cramer J.A., and French J. Quantitative assessment of seizure severity for clinical trials: a review of approaches to seizure components. Epilepsia 42 (2001) 119-129
7. Gelman A., Bios A., and Jiang J. Physiological pharmacokinetic analysis using population modelling and informative prior distribution. J. Am. Stat. Assoc. 91 (1996) 1400-1412
8. Hopkins A., Davies P., and Dobson S. Mathematical models of patterns of seizures. Their use in the evaluation of drugs. Arch. Neurol. 42 (1985) 463-467
9. Kwan P., and Brodie M.J. Early identification of refractory epilepsy. N. Engl. J. Med. 342 (2000) 314-319
10. Löscher W., and Potschka H. Role of multidrug transporters in pharmacoresistance to antiepileptic drugs. J. Pharmacol. Exp. Ther. 301 (2002) 7-14
11. Marson A.G., Kadir Z.A., and Chadwick D.W. New antiepileptic drugs: a systematic review of their efficacy and tolerability. Br. Med. J. 313 (1996) 1169-1174
12. Meencke H.J., and Buyle S. Assessment of a dose-response relationship of levetiracetam. Eur. J. Neurol. 13 (2006) 942-946
13. Miller R., Frame B., Corrigan B., Burger P., Bockbrader H., Garofalo E., and Lalonde R. Exposure-response analysis of pregabalin add-on treatment of patients with refractory partial seizures. Clin. Pharmacol. Ther. 73 (2003) 491-505
14. Patsalos P.N. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol. Ther. 85 (2000) 77-85
15. Shorvon S.D., Löwenthal A., Janz D., Bielen E., Loiseau P., and for the European Levetiracetam Study Group. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. Epilepsia 41 (2000) 1179-1186
16. Shorvon S.D. Levetiracetam. Handbook of Epilepsy Treatment (2000), Blackwell Science, Oxford pp. 113-116
17. Thall P.F., and Vail S.C. Some covariance models for longitudinal count data with overdispersion. Biometrics 46 (1990) 657-671
18. World Health Organization, 2004. WHO Drug Information. 18, p. 152. Available at http://www.who.int/druginformation/vol18num2-2004/DI18-2.pdf.
19. Yano Y., Beal S.L., and Sheiner L.B. Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check. J. Pharmacokinet. Pharmacodyn. 28 (2001) 171-192