drugset / Trial / NCT00438451
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
RandomizedParallel-groupDouble-blindTreatment
Summary
In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.
Timeline
- Start
- 2007-01
- Primary completion
- 2010-07
- Completion
- 2011-08
Publications
- Background Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, Spitz M, Frederick T, Towne A, Carter GS, Marks W, Felicetta J, Tomyanovich ML; VA Cooperative Study 428 Group. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology. 2005 Jun 14;64(11):1868-73. doi: 10.1212/01.WNL.0000167384.68207.3E.
- Background Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer SL, Maton S, Sauermann W, Murray G, Garofalo EA; Gabapentin Study Group 945-212. Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia. 2002 Sep;43(9):993-1000. doi: 10.1046/j.1528-1157.2002.45401.x.
- Werhahn KJ, Trinka E, Dobesberger J, Unterberger I, Baum P, Deckert-Schmitz M, Kniess T, Schmitz B, Bernedo V, Ruckes C, Ehrlich A, Kramer G. A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy. Epilepsia. 2015 Mar;56(3):450-9. doi: 10.1111/epi.12926. Epub 2015 Feb 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbamazepine | Small molecule | 200 mg | Oral |
| Comparator | Carbamazepine | Small molecule | 1200 mg | Oral |
| Comparator | Lamotrigine | Small molecule | 50 mg | Oral |
| Comparator | Lamotrigine | Small molecule | 300 mg | Oral |
| Comparator | Levetiracetam | Other / unclassified | 500 mg | Oral |
| Comparator | Levetiracetam | Other / unclassified | 3000 mg | Oral |