Monotherapy trials of new antiepileptic drugs

Epilepsia

Volumn 38, Issue SUPPL. 9, 1997, Pages S21-S31

  Beydoun, Ahmad ^a  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

Antiepileptic drugs; Clinical trials; Double blind trials; Epilepsy; Monotherapy

Indexed keywords

ANTICONVULSIVE AGENT; GABAPENTIN; OXCARBAZEPINE; TIAGABINE; TOPIRAMATE;

CLINICAL ARTICLE; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EPILEPSY; EPILEPTOGENESIS; FATIGUE; HEADACHE; HUMAN; HUMAN TISSUE; MULTICENTER STUDY; PARESTHESIA; PRIORITY JOURNAL; SEIZURE SUSCEPTIBILITY; VERTIGO;

EID: 0030694614     PISSN: 00139580     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1528-1157.1997.tb05201.x     Document Type: Conference Paper

References (25)

1. Privitera M, Fincham R, Penry J, et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages. Neurology 1996;46:1678-83.
2. French JA, Mosier M, Walker S, Sommerville K, Sussman N. A double-blind placebo-controlled study of vigabatrin 3 g/day in patients with uncontrolled complex partial seizures. Neurology 1996; 46:54-61.
3. French JA. What trials, which designs? Epilepsia 1997;38:263-5.
4. Chadwick D. Monotherapy clinical trials of new antiepileptic drugs: design, indications, and controversies. Epilepsia 1997;38 (suppl 9):S16-20 (this issue).
5. Leber PD. Hazards of inference: the active control investigation. Epilepsia 1989;30:S57-63.
6. Temple R. Government viewpoint of clinical trials. Drug Inform J 1982;1:10-7.
7. Anhut H, Ashman P, Feuerstein TJ, Sauermann W, Saunders M, Schmidt B. Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a double-blind, placebo-controlled study. The International Gabapentin Study Group. Epilepsia 1994;35:795-801.
8. UK Gabapentin Study Group. Gabapentin in partial epilepsy. Lancet 1990;335:1114-7.
9. U.S. Gabapentin Study Group No. 5. Gabapentin as add-on therapy in refractory partial epilepsy: a double-blind, placebo-controlled, parallel-group study. Neurology 1993;43:2292-8.
10. Beydoun A, Fisher J, Labar DR, et al. Gabapentin monotherapy. II. A 26-week, double-blind, dose-controlled, multicenter study of conversion from polytherapy in outpatients with refractory complex partial or secondarily generalized seizures. Neurology 1997;49:746-752.
11. Bergey GK, Morris HH, Rosenfeld W, et al. Gabapentin monotherapy. I: an 8-day, double-blind, dose-controlled, multicenter study in hospitalized patients with refractory complex partial or secondarily generalized seizures. Neurology 1997;49:739-745.
12. Chadwick D, Anhut H, Murray G, Greiner M, Alexander J, and the International Gabapentin Monotherapy Study Group (945-077). Gabapentin monotherapy in patients with newly-diagnosed epilepsy: results of a double-blind, fixed-dose study comparing three dosages of gabapentin and open-label carbamazepine [Abstract]. Epilepsia 1997;38(suppl 3):34.
13. Matsuo F, Bergen D, Faught E, et al. Placebo-controlled study of the efficacy and safety of lamotrigine in patients with partial seizures. Neurology 1993;43:2284-91.
14. Messenheimer J, Ramsay RE, Willmore LJ, et al. Lamotrigine therapy for partial seizures: a multicenter, placebo-controlled, double-blind, cross-over trial. Epilepsia 1994;35:113-21.
15. Brodie MJ, Richens A, Yuen AW, and the UK Lamotrigine/ Carbamazepine Monotherapy Trial Group. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. Lancet 1995;345:476-9.
16. Steiner TJ, Silveria C, Yuen AWC, and the North Thames Lamictal Study Group. Comparison of lamotrigine (Lamictal) and phenytoin monotherapy in newly diagnosed epilepsy [Abstract]. Epilepsia 1994;35(suppl 7):61.
17. Chang G, Vazquez B, Gilliam F, et al. Lamictal (lamotrigine) monotherapy is an effective treatment for partial seizures [Abstract]. Neurology 1997;48(suppl 2):A335.
18. Ayala R, Casale EJ, Brookins TA, Manasco P. The effectiveness and safety of Lamictal (lamotrigine) monotherapy for the treatment of newly-diagnosed typical absence seizures in children and adolescents [Abstract]. Epilepsia 1996;37(suppl 5):165.
19. Sachdeo RC, Reife RA, Lim P, Pledger G. Topiramate monotherapy for partial onset seizures. Epilepsia 1997;38:294-9.
20. Schachter S, Biton V, Boellner S, et al. Safety and efficacy of tiagabine HCl monotherapy in the treatment of partial seizures: high dose versus low dose [Abstract]. Epilepsia 1995;36(suppl 3):S148.
21. Schachter SC, Vasquez B, Fisher RS, et al. Monotherapy trial of oxcarbazepine for partial seizures in hospitalized presurgical patients [Abstract]. Epilepsia 1996;37(suppl 5):202.
22. Bourgeois B, Leppik IE, Sackellares JC, et al. Felbamate: a double-blind controlled trial in patients undergoing presurgical evaluation of partial seizures. Neurology 1993;43:693-6.
23. Beydoun A, Sackellares JC, Shu V, and the Depakote Monotherapy for Partial Seizures Study Group. Safety and efficacy of divalproex sodium monotherapy in partial epilepsy: a double-blind, concentration-response clinical trial. Neurology 1997;48: 182-8.
24. Faught E, Wilder BJ, Ramsay RE, et al. Topiramate placebo-controlled dose ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology 1996;46:1684-90.
25. Rowan J, Ahmann P, Wannamaker B, Schacter S, Rask C, Uthman B. Safety and efficacy of three dose levels of tiagabine HCl vs. placebo as adjunctive treatment for complex partial seizures [Abstract]. Epilepsia 1993;34(suppl 2):157.