Active-control antiepileptic drug trials in the newly diagnosed patient: Are we getting closer?

Epilepsy and Behavior

Volumn 3, Issue 2, 2002, Pages 109-112

  French, Jacqueline A ^a  

^a HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; LAMOTRIGINE; OXCARBAZEPINE; PHENYTOIN; PLACEBO; REMACEMIDE; VALPROIC ACID;

CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDITORIAL; ENZYME INDUCTION; EPILEPSY; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL ETHICS; METHODOLOGY; MONOTHERAPY; PATIENT CARE; RANDOMIZATION; SAMPLE SIZE; SEQUENTIAL ANALYSIS; TREATMENT FAILURE; TREATMENT OUTCOME; VERTIGO;

EID: 0036554819     PISSN: 15255050     EISSN: None     Source Type: Journal    
DOI: 10.1006/ebeh.2002.0340     Document Type: Editorial

References (19)

1. French JA. The art of antiepileptic trial design. Adv Neurol 1998;76:113-23.
2. French J, Dichter M. New antiepileptic drug development: Medical perspective. In: Levy R, Mattson R, Meldrum B, Perucca E, editors. Antiepileptic drugs, 5th ed. New York: Lippincott, Williams & Wilkins, 2002: in press.
3. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000;342:314-9.
4. Kwan P, Brodie MJ. Effectiveness of first antiepileptic drug. Epilepsia 2001;42:1255-60.
5. Gilliam F, Vazquez B, Sackellares JC, et al. An active-control trial of lamotrigine monotherapy for partial seizures. Neurology 1998;51:1018-25.
6. Beydoun A, Sachdeo RC, Rosenfeld WE, et al. Oxcarbazepine monotherapy for partial-onset seizures: a multicenter, double-blind, clinical trial. Neurology 2000;54:2245-51.
7. Chadwick DW, Anhut H, Greiner MJ, et al. A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. International Gabapentin Monotherapy Study Group 945-77. Neurology 1998;51:1282-8.
8. Chadwick D. Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study. Vigabatrin European Monotherapy Study Group. Lancet 1999;354:13-9.
9. Brodie MJ, Richens A, Yuen AW. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. UK Lamotrigine/Carbamazepine Monotherapy Trial Group. Lancet 1995;345:476-9.
10. Leber PD. Hazards of inference: the active control investigation. Epilepsia 1989;30(Suppl. 1):S57-63; discussion S64-8.
11. Christe W, Kramer G, Vigonius U, et al. A double-blind controlled clinical trial: oxcarbazepine versus sodium valproate in adults with newly diagnosed epilepsy. Epilepsy Res 1997;26:451-60.
12. Dam M, Ekberg R, Loyning Y, Waltimo O, Jakobsen K. A double-blind study comparing oxcarbazepine and carbamazepine in patients with newly diagnosed, previously untreated epilepsy. Epilepsy Res 1989;3:70-6.
13. Guerreiro MM, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in children and adolescents with epilepsy. Epilepsy Res 1997; 27:205-13.
14. Beydoun A, Kutluay E. Oxcarbazepine. Expert Opin Pharmacother 2002;3:59-71.
15. Chadwick D. Monotherapy clinical trials of new antiepileptic drugs: design, indications, and controversies. Epilepsia 1997;38(Suppl. 9):S16-20.
16. Chadwick D, Privitera M. Placebo-controlled studies in neurology: where do they stop? Neurology 1999;52:682-5.
17. Karlawish J, French J. The ethical and scientific shortcomings of current monotherapy epilepsy trials in newly diagnosed patients. Epilepsy Behav 2001;2:193-200.
18. French J. Active-control comparative equivalency monotherapy trials in epilepsy (letter to the editor). Epilepsy Behav 2001;2:613-4.
19. Whitehead J. Monotherapy trials: sequential design. Epilepsy Res 2001;45:81-7.