메뉴 건너뛰기




Volumn 91, Issue 1, 2010, Pages 1-9

RCTs with new antiepileptic drugs in children: A systematic review of monotherapy studies and their methodology

Author keywords

Efficacy; Methodology; RCT; Safety; Study design

Indexed keywords

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

EID: 77956010941     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2010.07.004     Document Type: Review
Times cited : (12)

References (45)
  • 1
    • 33746179120 scopus 로고    scopus 로고
    • Comparison of the cognitive effects of tiagabine and carbamazepine as monotherapy in newly diagnosed adult patients with partial epilepsy: pooled analysis of two long-term, randomized, follow-up studies
    • Aikia M., Jutila L., Salmenpera T., Mervaala E., Kalviainen R. Comparison of the cognitive effects of tiagabine and carbamazepine as monotherapy in newly diagnosed adult patients with partial epilepsy: pooled analysis of two long-term, randomized, follow-up studies. Epilepsia 2006, 47:1121-1127.
    • (2006) Epilepsia , vol.47 , pp. 1121-1127
    • Aikia, M.1    Jutila, L.2    Salmenpera, T.3    Mervaala, E.4    Kalviainen, R.5
  • 3
    • 0012853390 scopus 로고    scopus 로고
    • Topiramate: effective as monotherapy in dose-response study in newly diagnosed epilepsy
    • Arroyo S., Squires L., Wang S., Twyman R. Topiramate: effective as monotherapy in dose-response study in newly diagnosed epilepsy. Epilepsia 2002, 43(Suppl. 7):241.
    • (2002) Epilepsia , vol.43 , Issue.SUPPL. 7 , pp. 241
    • Arroyo, S.1    Squires, L.2    Wang, S.3    Twyman, R.4
  • 4
    • 0041914584 scopus 로고    scopus 로고
    • Sustained efficacy and long-term safety of oxcarbazepine: one-year open-label extension of a study in refractory partial epilepsy
    • Beydoun A., Sachdeo R.C., Kutluay E., McCague K., D'Souza J. Sustained efficacy and long-term safety of oxcarbazepine: one-year open-label extension of a study in refractory partial epilepsy. Epilepsia 2003, 44:1160-1165.
    • (2003) Epilepsia , vol.44 , pp. 1160-1165
    • Beydoun, A.1    Sachdeo, R.C.2    Kutluay, E.3    McCague, K.4    D'Souza, J.5
  • 6
    • 0037305116 scopus 로고    scopus 로고
    • Lamotrigine versus valproate monotherapy-associated weight change in adolescents with epilepsy: results from a post hoc analysis of a randomized, double-blind clinical trial
    • Biton V., Levisohn P., Hoyler S., Vuong A., Hammer A.E. Lamotrigine versus valproate monotherapy-associated weight change in adolescents with epilepsy: results from a post hoc analysis of a randomized, double-blind clinical trial. J. Child Neurol. 2003, 18:133-139.
    • (2003) J. Child Neurol. , vol.18 , pp. 133-139
    • Biton, V.1    Levisohn, P.2    Hoyler, S.3    Vuong, A.4    Hammer, A.E.5
  • 7
    • 0035936604 scopus 로고    scopus 로고
    • Weight change associated with valproate and lamotrigine monotherapy in patients with epilepsy
    • Biton V., Mirza W., Montouris G., Vuong A., Hammer A.E., Barrett P.S. Weight change associated with valproate and lamotrigine monotherapy in patients with epilepsy. Neurology 2001, 56:172-177.
    • (2001) Neurology , vol.56 , pp. 172-177
    • Biton, V.1    Mirza, W.2    Montouris, G.3    Vuong, A.4    Hammer, A.E.5    Barrett, P.S.6
  • 8
    • 0000355269 scopus 로고    scopus 로고
    • Gabapentin (Neurontin) monotherapy in children with benign childhood epilepsy with centrotemporal spikes (BECTS): a 36-week, double-blind, placebo-controlled study
    • Bourgeois B., Brown L.W., Pellock J.M., Buroker M., Greiner M., Garofalo E.A., Schimschock J.R., Griesemer D., Bebin M.E., Murphy J.V. Gabapentin (Neurontin) monotherapy in children with benign childhood epilepsy with centrotemporal spikes (BECTS): a 36-week, double-blind, placebo-controlled study. Epilepsia 1998, 39(Suppl. 6):163.
    • (1998) Epilepsia , vol.39 , Issue.SUPPL. 6 , pp. 163
    • Bourgeois, B.1    Brown, L.W.2    Pellock, J.M.3    Buroker, M.4    Greiner, M.5    Garofalo, E.A.6    Schimschock, J.R.7    Griesemer, D.8    Bebin, M.E.9    Murphy, J.V.10
  • 10
    • 15844391803 scopus 로고    scopus 로고
    • Complaints associated with the use of antiepileptic drugs: results from a community-based study
    • Carpay J.A., Aldenkamp A.P., van Donselaar C.A. Complaints associated with the use of antiepileptic drugs: results from a community-based study. Seizure 2005, 14:198-206.
    • (2005) Seizure , vol.14 , pp. 198-206
    • Carpay, J.A.1    Aldenkamp, A.P.2    van Donselaar, C.A.3
  • 11
    • 0031775386 scopus 로고    scopus 로고
    • A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77
    • Chadwick D.W., Anhut H., Greiner M.J., Alexander J., Murray G.H., Garofalo E.A., Pierce M.W. A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77. Neurology 1998, 51:1282-1288.
    • (1998) Neurology , vol.51 , pp. 1282-1288
    • Chadwick, D.W.1    Anhut, H.2    Greiner, M.J.3    Alexander, J.4    Murray, G.H.5    Garofalo, E.A.6    Pierce, M.W.7
  • 12
    • 46349101069 scopus 로고    scopus 로고
    • Use of second-generation antiepileptic drugs in the pediatric population
    • Chung A.M., Eiland L.S. Use of second-generation antiepileptic drugs in the pediatric population. Paediatr. Drugs 2008, 10:217-254.
    • (2008) Paediatr. Drugs , vol.10 , pp. 217-254
    • Chung, A.M.1    Eiland, L.S.2
  • 13
    • 0019509687 scopus 로고
    • Proposal for revised clinical and electroencephalographic classification of epileptic seizures
    • Commission on Classification and Terminology of the International League Against Epilepsy
    • Commission on Classification and Terminology of the International League Against Epilepsy Proposal for revised clinical and electroencephalographic classification of epileptic seizures. Epilepsia 1981, 22:489-501.
    • (1981) Epilepsia , vol.22 , pp. 489-501
  • 14
    • 0024317220 scopus 로고
    • Proposal for revised classification of epilepsies and epileptic syndromes
    • Commission on Classification and Terminology of the International League Against Epilepsy
    • Commission on Classification and Terminology of the International League Against Epilepsy Proposal for revised classification of epilepsies and epileptic syndromes. Epilepsia 1989, 30:389-399.
    • (1989) Epilepsia , vol.30 , pp. 389-399
  • 15
    • 4544220589 scopus 로고    scopus 로고
    • Lamotrigine versus valproic acid as first-line monotherapy in newly diagnosed typical absence seizures: an open-label, randomized, parallel-group study
    • Coppola G., Auricchio G., Federico R., Carotenuto M., Pascotto A. Lamotrigine versus valproic acid as first-line monotherapy in newly diagnosed typical absence seizures: an open-label, randomized, parallel-group study. Epilepsia 2004, 45:1049-1053.
    • (2004) Epilepsia , vol.45 , pp. 1049-1053
    • Coppola, G.1    Auricchio, G.2    Federico, R.3    Carotenuto, M.4    Pascotto, A.5
  • 16
    • 33947612119 scopus 로고    scopus 로고
    • Levetiracetam or oxcarbazepine as monotherapy in newly diagnosed benign epilepsy of childhood with centrotemporal spikes (BECTS): an open-label, parallel group trial
    • Coppola G., Franzoni E., Verrotti A., Garone C., Sarajlija J., Felicia Operto F., Pascotto A. Levetiracetam or oxcarbazepine as monotherapy in newly diagnosed benign epilepsy of childhood with centrotemporal spikes (BECTS): an open-label, parallel group trial. Brain Dev. 2007, 29:281-284.
    • (2007) Brain Dev. , vol.29 , pp. 281-284
    • Coppola, G.1    Franzoni, E.2    Verrotti, A.3    Garone, C.4    Sarajlija, J.5    Felicia Operto, F.6    Pascotto, A.7
  • 17
    • 0033544351 scopus 로고    scopus 로고
    • A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Lamictal Pediatric Partial Seizure Study Group
    • Duchowny M., Pellock J.M., Graf W.D., Billard C., Gilman J., Casale E., Womble G., Risner M., Manasco P. A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Lamictal Pediatric Partial Seizure Study Group. Neurology 1999, 53:1724-1731.
    • (1999) Neurology , vol.53 , pp. 1724-1731
    • Duchowny, M.1    Pellock, J.M.2    Graf, W.D.3    Billard, C.4    Gilman, J.5    Casale, E.6    Womble, G.7    Risner, M.8    Manasco, P.9
  • 18
    • 29444443770 scopus 로고    scopus 로고
    • Issues in paediatric epilepsy
    • Dulac O. Issues in paediatric epilepsy. Acta Neurol. Scand. 2005, (Suppl. 182):9-11.
    • (2005) Acta Neurol. Scand. , Issue.SUPPL. 182 , pp. 9-11
    • Dulac, O.1
  • 19
    • 33745128497 scopus 로고    scopus 로고
    • EMEA/CHMP/EWP/5872/03 Corr., European Medicines Agency (Committee for Medicinal Products for Human use)
    • European Medicines Agency (Committee for Medicinal Products for Human use) Guideline on Data Monitoring Committees 2005, EMEA/CHMP/EWP/5872/03 Corr.
    • (2005) Guideline on Data Monitoring Committees
  • 20
    • 74049137197 scopus 로고    scopus 로고
    • A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
    • Fernandes R.M., van der Lee J.H., Offringa M. A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr. 2009, 9:77.
    • (2009) BMC Pediatr. , vol.9 , pp. 77
    • Fernandes, R.M.1    van der Lee, J.H.2    Offringa, M.3
  • 25
  • 28
    • 0027132477 scopus 로고
    • Felbamate in the treatment of refractory partial-onset seizures
    • Jensen P.K. Felbamate in the treatment of refractory partial-onset seizures. Epilepsia 1993, 34(Suppl. 7):S25-S29.
    • (1993) Epilepsia , vol.34 , Issue.SUPPL. 7
    • Jensen, P.K.1
  • 30
    • 0033779616 scopus 로고    scopus 로고
    • Gabapentin versus vigabatrin as first add-on for patients with partial seizures that failed to respond to monotherapy: a randomized, double-blind, dose titration study. GREAT Study Investigators Group. Gabapentin in Refractory Epilepsy Add-on Treatment
    • Lindberger M., Alenius M., Frisen L., Johannessen S.I., Larsson S., Malmgren K., Tomson T. Gabapentin versus vigabatrin as first add-on for patients with partial seizures that failed to respond to monotherapy: a randomized, double-blind, dose titration study. GREAT Study Investigators Group. Gabapentin in Refractory Epilepsy Add-on Treatment. Epilepsia 2000, 41:1289-1295.
    • (2000) Epilepsia , vol.41 , pp. 1289-1295
    • Lindberger, M.1    Alenius, M.2    Frisen, L.3    Johannessen, S.I.4    Larsson, S.5    Malmgren, K.6    Tomson, T.7
  • 31
    • 0034905574 scopus 로고    scopus 로고
    • A comparison of monotherapy with lamotrigine or carbamazepine in patients with newly diagnosed partial epilepsy
    • Nieto-Barrera M., Brozmanova M., Capovilla G., Christe W., Pedersen B., Kane K., O'Neill F. A comparison of monotherapy with lamotrigine or carbamazepine in patients with newly diagnosed partial epilepsy. Epilepsy Res. 2001, 46:145-155.
    • (2001) Epilepsy Res. , vol.46 , pp. 145-155
    • Nieto-Barrera, M.1    Brozmanova, M.2    Capovilla, G.3    Christe, W.4    Pedersen, B.5    Kane, K.6    O'Neill, F.7
  • 33
    • 0033066534 scopus 로고    scopus 로고
    • Monotherapy trials with the new antiepileptic drugs: study designs, practical relevance and ethical implications
    • Perucca E., Tomson T. Monotherapy trials with the new antiepileptic drugs: study designs, practical relevance and ethical implications. Epilepsy Res. 1999, 33:247-262.
    • (1999) Epilepsy Res. , vol.33 , pp. 247-262
    • Perucca, E.1    Tomson, T.2
  • 34
    • 0037354372 scopus 로고    scopus 로고
    • Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy
    • Privitera M.D., Brodie M.J., Mattson R.H., Chadwick D.W., Neto W., Wang S. Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy. Acta Neurol. Scand. 2003, 107:165-175.
    • (2003) Acta Neurol. Scand. , vol.107 , pp. 165-175
    • Privitera, M.D.1    Brodie, M.J.2    Mattson, R.H.3    Chadwick, D.W.4    Neto, W.5    Wang, S.6
  • 37
    • 67849118449 scopus 로고    scopus 로고
    • A multicenter, outpatient, open-label study to evaluate the dosing, effectiveness, and safety of topiramate as monotherapy in the treatment of epilepsy in clinical practice
    • Sankar R., Ramsay E., McKay A., Hulihan J., Wiegand F. A multicenter, outpatient, open-label study to evaluate the dosing, effectiveness, and safety of topiramate as monotherapy in the treatment of epilepsy in clinical practice. Epilepsy Behav. 2009, 15:506-512.
    • (2009) Epilepsy Behav. , vol.15 , pp. 506-512
    • Sankar, R.1    Ramsay, E.2    McKay, A.3    Hulihan, J.4    Wiegand, F.5
  • 39
    • 85047692188 scopus 로고
    • Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials
    • Schulz K.F., Chalmers I., Hayes R.J., Altman D.G. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995, 273:408-412.
    • (1995) JAMA , vol.273 , pp. 408-412
    • Schulz, K.F.1    Chalmers, I.2    Hayes, R.J.3    Altman, D.G.4
  • 40
    • 0036756071 scopus 로고    scopus 로고
    • Gabapentin and lamotrigine in Indian patients of partial epilepsy refractory to carbamazepine
    • Sethi A., Chandra D., Puri V., Mallika V. Gabapentin and lamotrigine in Indian patients of partial epilepsy refractory to carbamazepine. Neurol. India 2002, 50:359-363.
    • (2002) Neurol. India , vol.50 , pp. 359-363
    • Sethi, A.1    Chandra, D.2    Puri, V.3    Mallika, V.4
  • 42
    • 0029803259 scopus 로고    scopus 로고
    • Gabapentin in naive childhood absence epilepsy: results from two double-blind, placebo-controlled, multicenter studies
    • Trudeau V., Myers S., LaMoreaux L., Anhut H., Garofalo E., Ebersole J. Gabapentin in naive childhood absence epilepsy: results from two double-blind, placebo-controlled, multicenter studies. J. Child Neurol. 1996, 11:470-475.
    • (1996) J. Child Neurol. , vol.11 , pp. 470-475
    • Trudeau, V.1    Myers, S.2    LaMoreaux, L.3    Anhut, H.4    Garofalo, E.5    Ebersole, J.6
  • 45
    • 12144287824 scopus 로고    scopus 로고
    • Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy
    • Wheless J.W., Neto W., Wang S. Topiramate, carbamazepine, and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. J. Child Neurol. 2004, 19:135-141.
    • (2004) J. Child Neurol. , vol.19 , pp. 135-141
    • Wheless, J.W.1    Neto, W.2    Wang, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.