Clinical trials for antiepileptic drugs: From add-on to monotherapy and dose-related designs

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 685-695

  Möckel, Volker ^a  

^a Parke Davis GmbH Berlin   (Germany)

Author keywords

Add on design; Equivalence design; Monotherapy design; Parallel group design

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; CLOBAZAM; GABAPENTIN; LAMOTRIGINE; PHENOBARBITAL; PHENYTOIN; PLACEBO; PROGABIDE; VALPROIC ACID; VIGABATRIN;

ANTICONVULSANT ACTIVITY; ARTICLE; CLINICAL TRIAL; DOSE CALCULATION; DRUG EFFICACY; DRUG MIXTURE; DRUG RESEARCH; DRUG SCREENING; EPILEPSY; PRIORITY JOURNAL;

EID: 1842366741     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100309     Document Type: Article

References (41)

1. Schmidt D. Evaluation of clinical efficacy in antiepileptic drugs trial. Epilepsy Res. 1991; Suppl. 3: 68-78.
2. Richens A. Rational polypharmacy. Seizure. 1995; 4:211-214.
3. Wilensky AJ. Protocol design. In: French JA, Dichter MA, Leppik IE (eds.). New Antiepileptic Drug Development: Preclinical and Clinical Aspects. Amsterdam: Elsevier Science; 1993:107-113.
4. Schmidt D. Reduction of two-drug therapy in intractable epilepsy. Epilepsia. 1983;24:368-376.
5. Leppik IE. Sources for variability in clinical trials of new drugs for epilepsy. In: French JA, Dichter MA, Leppik IE (eds.). New Antiepileptic Drug Development: Preclinical and Clinical Aspects. Amsterdam: Elsevier Science; 1993:157-166.
6. Senn SJ. Crossover at the crossroads. Appl Clin Trials. 1995;4:24-31.
7. Dambrosia JM. Statistical and epidemiological considerations. In: Porter RJ, Schoenberg BS (eds.). Controlled clinical trials in neurological disease. Boston: Kluwer Academic Publishers; 1990:29-51.
8. Gram L, Schmidt D. Innovative designs of controlled clinical trials in epilepsy. Epilepsia. 1993;34 (Suppl. 7):S1-S6.
9. Pledger GW, Schmidt D. Evaluation of antiepileptic drug efficacy. Drugs. 1994;48:498-509.
10. Brodie MJ. Antiepileptic drugs, clinical trials, and the marketplace. The Lancet. 1996;347:777-778.
11. Rodin EA, Rim CS, Rennick PM. The effects of carbamazepine on patients with psychomotor epilepsy: results of a double-blind study. Epilepsia. 1974;15:547-561.
12. Richens A, Ahmad S. Controlled trial of sodium valproate in severe epilepsy. Br Med J. 1975;4:255-256.
13. Leppik IE, Dreifuss FE, Porter R, et al. A controlled study of progabide in partial seizures: methodology and results. Neurology. 1987;37:963-968.
14. Cereghino JJ. Clinical trial design for antiepileptic drugs. Ann Neurology. 1992;32:393-394.
15. Wilensky AJ, Friel PN, Ojemann LM, Kupferberg HJ, Levy RH. Pharmacokinetics of W-554 in epileptic patients. Epilepsia. 1985;26:602-606.
16. Binnie C. Design of clinical antiepileptic drug trials. Seizure. 1995;4:187-192.
17. Temkin NR, Wilensky A. New AEDs: are the compounds or the studies ineffective? Epilepsia. 1986; 44:645.
18. Gram L, Wulff K, Rasmussen KE, et al. Valproate sodium: a controlled clinical trial including monitoring of serum levels. Epilepsia. 1977;18:141-148.
19. Jawad S, Richens A, Goodwin R, et al. Controlled trial of lamotrigine (lamictal) for refractory partial seizures. Epilepsia. 1989;30: 56-363.
20. Binnie C, Debets R, Engelsman M, et al. Double-blind cross-over trial of lamotrigine (lamictal) as add-on therapy in intractable seizures. Epilepsy Res. 1989;4:222-229.
21. Sanathanan LP, Peck CC. The randomized concentration-controlled trial: an evaluation of its sample size efficiency. Contr Clin Trials. 1991;12:780-794.
22. Dam M, Gram L, Mumford JP. Design of clinical trials of new antiepileptic drugs. In: Levy R, Mattson R, Meldrum BS (eds.). Antiepileptic drugs. Fourth ed. New York: Raven Press, Ltd.; 1995:111-122.
23. Baber NS, Smith NS. Clinical Trials. In: Griffin JP, O'Grady J, Wells FO (eds.). Textbook of Pharmaceutical Medicine. Belfast: W&G Baird Ltd.; 1993:229-290.
24. Chadwick D, Richens A, Ducan J, Dam M, Morrow J, Gram L, Mengel H, Shu V, McKelvy F, Pierce M. Tiagabine HCl: Safety and efficacy as adjunctive treatment for complex partial seizures. Epilepsia. 1991;32:20.
25. Richens A, Chadwick D, Ducan J, Dam M, Morrow J, Gram L, Mengel H, Shu V, Pierce M, Rask C, Highthower B. Safety and efficacy of tiagabine HCl as adjunctive treatment for complex partial seizures. Epilepsia. 1992;33:119.
26. Katz R. Perspectives of the Food and Drug Administration. In: Porter RJ, Schoenberg BS (eds.). Controlled Clinical Trials in Neurological Disease. Boston: Kluwer Academic Publishers; 1990:85-96.
27. R) in pediatriC patients with benign childhood epilepsy with centrotemporal spikes (BECTS). Epilepsia. 1995;36 (Suppl. 3):125.
28. Pledger GW, Sahlroot JT. Alternative analyses for antiepileptic drug trials. New Antiepileptic Drug Development: Preclinical and Clinical Aspects. Amsterdam: Elsevier Science; 1993:167-174.
29. Senn SJ. Clinical trials and epidemiology. J Clin Epidemiol. 1990;43:628-632.
30. Garbe E, Röhmel J, Gundert-Remy U. Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol. 1993;45:1-7.
31. Balkenohl M, Greiner M, Murray G, The International Gabapentin Monotherapy Study Group (945-92). Gabapentin monotherapy in patients with partial epilepsy: A double-blind flexible dose-range comparison study versus carbamazepine (Abstract for the European Epilepsy Meeting 1996). Epilepsia. 1996.
32. Kieser M. A confirmatory strategy for therapeutic equivalence trials. Int J Clin Pharmacol Therapeut. 1995;33:388-390.
33. Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. J Biopharmaceutical Stat. 1995; 5:297-306.
34. Bourgeois B, Leppik IE, Sackellarees JC, et al. A double-blind controlled trial in patients undergoing presurgical evaluation of partial seizures. Neurology. 1993;43:693-696.
35. R) monotherapy in hospitalized patients with refractory epilepsy. Epilepsia. 1995;36 (Suppl. 4):68.
36. French JA. In: French JA, Dichter MA, Leppik IE (eds.). New Antiepileptic Drug Development: Preclinical and Clinical Aspects. Amsterdam: Elsevier Science; 1993:81-89.
37. Faught RE, Sachedo RC, Remler M, et al. Felbamate monotherapy for partial onset seizures: an active control trial. Neurology. 1993;43:688-692.
38. Sachedo RC, Kramer LD, Rosenberg A, et al. Felbamate monotherapy: controlled trial in patients with partial onset seizures. Ann Neurol. 1992;32:385-392.
39. Pledger GW, Kramer DL. Clinical trials of investigational antiepileptic drugs: monotherapy designs. Epilepsia. 1991;32:716-721.
40. Sheiner LD, Hoshimoto Y, Beal SL. A stimulation study comparing designs for dose-ranging. Stat Med. 1991;10:303-321.
41. R) as monotherapy in newly diagnosed patients with partial epilepsy. Epilepsia. 1995;36 (Suppl. 3):119.